Journal of Cardiothoracic and Vascular Anesthesia
Volume 17, Issue 1 , Pages 17-21, February 2003

A case series of low-dose fenoldopam in seventy cardiac surgical patients at increased risk of renal dysfunction☆

Department of Anesthesiology, Yale University School of Medicine, New Haven, CT; and the Department of Anesthesiology, Wiell Medical College of Cornell University, New York, NY.

Article Outline

Abstract 

Objective: To evaluate the usefulness of low-dose fenoldopam mesylate in patients at risk of developing renal dysfunction after cardiac surgery requiring cardiopulmonary bypass. Design: A prospective, single-center, observational study. Setting: University teaching hospital. Participants: Seventy patients scheduled for elective cardiac surgery with one or more predefined risk factors for renal dysfunction. Interventions: After induction of anesthesia, fenoldopam (0.03 μg/kg/min) was administered throughout surgery and into the postoperative period, until the patient was stable and weaned from all other vasoactive agents. Perioperatively, fenoldopam was also used as a second-line antihypertensive agent as required. Measurements and Main Results: No patient developed renal failure that required dialysis, whereas 7.1% (5/70) developed non–dialysis-dependent renal dysfunction. Four out of these 5 patients had 2 or more risk factors (9.5%). Higher preoperative creatinine levels, a history of hypertension, myocardial infarction within 5 days of surgery, and a preoperative diagnosis of chronic renal insufficiency were all good predictors of postoperative non–dialysis-dependent renal dysfunction. Discharge serum creatinine levels were lower than preoperative levels (1.16 ± 0.36 mg/dL v 1.26 ± 0.34 mg/dL, p < 0.05). Conclusion: These findings suggest that renal function was preserved in patients at increased risk for renal dysfunction after cardiac surgery when low-dose fenoldopam was used in the perioperative period. However, a randomized, controlled trial is required to establish efficacy. Copyright 2003, Elsevier Science (USA). All rights reserved.

Keywords:  renal dysfunction, renal protection, cardiac surgery, cardiopulmonary bypass, fenoldopam

 

Renal dysfunction after cardiac surgery affects more than 46,000 patients each year in the United States1 and contributes to increased perioperative morbidity and mortality. Importantly, renal dysfunction is also associated with increased hospital resource utilization secondary to increased use of intensive care facilities and duration of stay, as well as subsequent follow-up.1, 2, 3, 4

Perioperative studies have shown that regional renal blood flow changes, increased renal vascular resistance, and decreased renal blood flow and glomerular filtration rates occur during cardiopulmonary bypass (CPB), thus increasing the potential for renal dysfunction.5, 6 Five independent preoperative predictors of renal dysfunction have been identified as: increased age (70 years or older), pre-existing heart failure, previous myocardial revascularization, type 1 (insulin-dependent) diabetes mellitus, and elevated preoperative serum creatinine.1 Other perioperative factors that exacerbate risk includes prolonged CPB times and significant intraoperative ventricular dysfunction.1

Despite the recognition of predisposing risk factors and the costs of renal dysfunction, current therapeutic options during cardiac surgery are limited. Temperature management regimens,7 increased perfusion pressure or pump flow,5, 8, 9, 10 and pulsatile versus nonpulsatile CPB11, 12, 13 have all been studied, but benefits have been inconsistent. Dopamine14, 15, 16, 17 and mannitol7 have traditionally been the most commonly used renoprotective agents, whereas there has been a more recent interest in the use of alpha2-adrenergic receptor agonists.18, 19 Nevertheless, the results of these studies have been variable and the patient benefits questioned.20, 21

Fenoldopam mesylate (Corlopam®; Abbott Laboratories, Abbott Park, IL) is a short-acting dopamine-1 (D1) agonist indicated for perioperative use in hypertensive urgencies and emergencies.22 Its antihypertensive properties are mediated through peripheral vasodilation via stimulation of D1 receptors.22 Of particular interest, however, the selective dopaminergic action of fenoldopam appears to improve renal performance in situations of reduced renal blood flow such as severe hypertension,23, 24 hypertensive crisis,25 hypertensive patients with pre-existing impaired renal function,26 and ventilation with positive end-expiratory pressure.27 These effects are mediated by an increased renal blood flow (to both cortex and medullary regions) associated with fenoldopam. Fenoldopam, therefore, may have some utility during CPB in which renal ischemia is thought to be one of the factors contributing to postbypass renal dysfunction.

This prospective, observational study, therefore, aimed to evaluate the usefulness of fenoldopam in preserving renal function in patients with one or more previously defined1 risk factors for the development of renal dysfunction after CPB.

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Methods 

This was an Institutional Review Board–approved, prospective, observational single-center study of the use of fenoldopam mesylate in patients undergoing cardiac surgery with CPB. Male and nonpregnant female patients over the age of 18 years who were scheduled for elective cardiac surgery using CPB were invited to participate in this study. Each patient was required to have a preoperative serum creatinine less than or equal to 2.0 mg/dL, and one or more of the following previously defined risk factors1 to be considered eligible for the study: age greater than or equal to 70 years, prior coronary artery bypass surgery, history of New York Heart Association class III or IV heart failure, history of type I diabetes mellitus or screening serum glucose greater than or equal to 300 mg/dL, or a preoperative serum creatinine greater than or equal to 1.4 mg/dL.

Patients who were precluded from the study were those who had a known allergy to fenoldopam mesylate, in whom dopaminergic agents were contraindicated, who were already receiving dopaminergic medication, who required emergency cardiac surgery, who required either acute or chronic dialysis 7 days before surgery, who had evidence of unstable renal function, who used a mechanical ventricular assist device, or who were in cardiogenic shock.

All patients received their routine daily cardiac medications before surgery. All standard American Society of Anesthesiologists' noninvasive monitors and peripheral intravenous and intra-arterial catheters were placed before induction. Anesthesia was induced using sufentanil (2-5 μg/kg) and midazolam (0.03-0.05 mg/kg). Intubation was facilitated with pancuronium. Patients were ventilated with a volume-controlled ventilator to achieve normocapnia (PaC02 = 36-44 mmHg). A flow-directed pulmonary artery catheter, transesophageal echocardiography probe, Foley catheter, and temperature probes (esophageal and bladder) were inserted after induction. Anesthesia was maintained with a continuous infusion of sufentanil (up to 1 μg/kg/hr pre-CPB and 0.15 μg/kg/hr during and after CPB) and midazolam (up to 0.2 μg/kg/min pre-CPB and 0.05 μg/kg/min during and after CPB). No volatile anesthetic agents were used, and muscle relaxation was achieved by using pancuronium.

Fenoldopam was infused centrally at a rate of 0.03 μg/kg/min after induction of anesthesia and insertion of the pulmonary artery catheter. The infusion was maintained continuously throughout surgery and the postoperative period until the patient was stable and weaned from all other vasoactive agents.

During the perioperative period, once the maximum dose of the sufentanil and midazolam infusion had been reached, fenoldopam was used as a second-line antihypertensive agent after 2 μg/kg/min of nitroglycerin was initiated. Fenoldopam dosing was achieved by up-titrating the dose from 0.03 μg/kg/min as clinically appropriate. If necessary during surgery, a bolus dose of fenoldopam (20-40 μg) was given before the increased infusion rate to achieve rapid blood pressure control.

Intraoperative systolic blood pressure was maintained within 20% of the patient's baseline pressure (the average of 3 preoperative readings) during the pre-CPB period and at 90 to 130 mmHg systolic after separation from CPB. Nonpulsatile perfusion pressure (mean arterial pressure) was maintained between 50 and 80 mmHg during CPB. Hypertension and hypotension were defined as pressures outside these specified ranges; episodes of hypertension and hypotension were treated as clinically appropriate, to remain within the specified ranges during the intraoperative period. Hemodynamic control, in both the intensive care and stepdown units, was per routine postsurgical care.

Renal dysfunction was defined as a postoperative serum creatinine level ≥2.0 mg/dL with an increase in serum creatinine levels of ≥0.7 mg/dL from preoperative to maximum postoperative values1 not requiring dialysis. The postoperative need for dialysis was determined by using the standard clinical protocols established at this institution.

Data were collected in the pre-, intra-, and postoperative periods. The primary endpoint of the study was the number of patients developing renal dysfunction during their hospitalization. Secondary endpoints included postoperative serum creatinine levels, as well as length of postoperative intensive care unit (ICU) stay, and hospital stay. Clinical adverse events were used to assess the safety and tolerability of low-dose fenoldopam. Preoperative and postoperative serum creatinine levels were determined by photospectrometry by using a Hitachi 747-200 (Hitachi, Tokyo, Japan).

Data were analyzed by using paired Student t-test, Mann-Whitney U test, risk ratios, Fisher exact test, and logistic regression as appropriate. The SPSS (SPSS Inc, Chicago, IL) statistical package was used for all analyses. Values are reported as means ± SD or medians (lower 95% percentile − upper 95% percentile) unless otherwise noted. A p value <0.05 was considered statistically significant.

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Results 

Seventy patients were enrolled. The mean age of the patients was 69.3 ± 10.6 years (range, 44-92 years), and the mean preoperative serum creatinine was 1.2 ± 0.36 mg/dL (range, 0.7-2.0 mg/dL). Other characteristics are listed in Tables 1 and 2. Of the 70 patients enrolled, 60% (42/70) had 2 or more risk factors (Table 1) and were considered to be at high risk for postoperative renal dysfunction.1

Table 1. Patient characteristics and outcome data
Baseline patient characteristics N (%)
Male46 (65.7)
Female24 (34.3)
Coronary artery bypass surgery49 (70.0)
Valve surgery13 (18.6)
Coronary artery bypass surgery + valve surgery6 (8.6)
Other2 (2.9%)
Age ≥7048 (68.6%)
Previous revascularization12 (17.1%)
Insulin-dependent diabetes mellitus23 (32.9%)
Heart failure26 (37.1%)
Preoperative creatinine ≥1.4 mg/dL26 (37.1%)
Number of risk factors N (%)
128 (40.0%)
225 (35.7%)
311 (15.7%)
46 (8.6%)
Outcome data
Highest postoperative creatinine1.46 ± 0.54 mg/dL
Discharge creatinine1.16 ± 0.36 mg/dL
Days in ICU2.0 (3.16-5.67) d
Days in hospital7.0 (6.91-9.43) d

Abbreviation: ICU, intensive care unit.

Table 2. Percentage of patients developing non–dialysis-dependent renal dysfunction in the current study compared with the reference study1
% Patients With Risk Factor Without Non–Dialysis-Dependent Renal Dysfunction% Patients With Risk Factor Developing Non–Dialysis-Dependent Renal Dysfunction
Risk factorReference StudyCurrent StudyReference StudyCurrent StudyUnadjusted Relative Risk in Current Study
Age ≥70 years88941261.83 (0.22-15.48)
Previous CABG851001500.00
IDDM86911491.36 (0.24-7.60)
CHF84961641.13 (0.20-6.32)
Preoperative creatinine ≥1.4 mg/dL838517156.77 (0.80-57.40)

Abbreviations: CABG, coronary artery bypass surgery; IDDM, insulin-dependent diabetes mellitus; CHF, congestive heart failure.

All 70 study patients received fenoldopam for renal protection and tolerated the infusion (0.03 μg/kg/min) over the planned infusion period without the need for withdrawal. Twenty-four (34.3%) patients administered fenoldopam in the operating room received up to 0.8 μg/kg/min (median, 0.3 μg/kg/min) for blood pressure control; 9 of them also received bolus doses. Overall, the mean total CPB time was 102.0 ± 28.6 minutes with a mean aortic cross-clamp time of 71.5 ± 28.1 minutes.

No patients required dialysis in the postoperative period. Five patients (7.1%) developed non–dialysis-dependent renal dysfunction, as previously defined. Postoperatively, the mean highest serum creatinine was significantly higher than the mean preoperative level (1.46 ± 0.54 mg/dL v 1.26 ± 0.34 mg/dL, p < 0.0001). However, the serum creatinine levels then decreased significantly from this postoperative peak to a lower discharge level (1.16 ± 0.36 mg/dL v 1.46 ± 0.54 mg/dL, p = 0.0001). This mean discharge level was also lower than the preoperative level (1.16 ± 0.36 mg/dL v 1.26 ± 0.34 mg/dL, p < 0.0001). For the group, serum creatinine levels appeared to peak on days 2 to 3 then declined toward discharge levels thereafter (Fig 1).

Four out of 5 patients who experienced postoperative non–dialysis-dependent renal dysfunction had 2 or more of the previously published1 risk factors (9.5%, 4/42). Of the patients with preoperative creatinine greater than 1.4 mg/dL, 15.4% (4/26) experienced non–dialysis-dependent renal dysfunction compared with 2.3% (1/44) of those without this risk factor. In patients who developed non–dialysis-dependent renal dysfunction, 3.6% (1/28) had 1 risk factor, 12.5% (3/24) had 2 risk factors, and 9.1% (1/11) had 3 risk factors; no patient developing non–dialysis-dependent renal dysfunction in this study had 4 or more risk factors.

Compared with the other patients, the 5 patients who developed non–dialysis-dependent renal dysfunction had higher preoperative creatinine levels (1.58 ± 0.31 v 1.23 ± 0.32 mg/dL, p = 0.020), and all had a history of hypertension. Patients who had sustained a myocardial infarction within 5 days of surgery were also at higher risk of renal failure (16.7%, 2/12 v 5.2%, 3/58; p = 0.049); recent myocardial infarction was considered to be the best predictor of postoperative non–dialysis-dependent renal dysfunction in this patient group.

With respect to the previously defined preoperative risk factors, a preoperative serum creatinine ≥1.4 mg/dL had the highest relative risk for developing non–dialysis-dependent renal dysfunction (Table 2). Except for a preoperative serum creatinine ≥1.4 mg/dL, the presence of one of the previously defined risk factors was associated with a lower proportion of patients developing non–dialysis-dependent renal dysfunction in the current study (Table 2) when compared with the reference study.1

A documented diagnosis of preoperative chronic renal insufficiency was also a good predictor of postoperative non–dialysis-dependent renal dysfunction; patients with preoperative chronic renal insufficiency were 5.4 (0.99-44.12) times more likely to experience postoperative non–dialysis-dependent renal dysfunction than patients who did not have chronic renal insufficiency (20%, 3/15 v 3.7%, 2/55; p = 0.065). Patients with peripheral vascular disease were 5.6 (1.07-59.63) times more likely to experience postoperative non–dialysis-dependent renal dysfunction than patients who did not have the risk factor (28.6%, 2/7 v 4.8%, 3/63; p = 0.077).

The preoperative creatinine level was the best predictor of elevated postoperative creatinine levels (r = 0.762, p < 0.001). Preoperative blood urea nitrogen levels were also predictive of an elevated postoperative creatinine (r = 0.439, p < 0.001) but were not independent of preoperative creatinine. Patients with above median (≥1.4 mg/dL) highest creatinine had significantly higher preoperative blood urea nitrogen levels (26.3 ± 10.62 v 19.0 ± 7.14 g/L, p = 0.001) and higher preoperative creatinine (1.48 ± 0.24 v 1.00 ± 0.19 mg/dL, p < 0.001).

On average, the length of stay in the ICU was 2.0 (3.16-5.67) days, with a total hospitalization length of stay of 7.0 (6.91-9.43) days. There was no difference in ICU length of stay between patients who developed non–dialysis-dependent renal dysfunction and those who did not (2.0 [0.16-6.16] days v 2.0 [1.93-4.19] days; p = 0.626). Similarly, there was no difference in total hospitalization length of stay between the 2 groups (7.0 [3.69-14.71] days v 6.0 [6.48-8.92] days; p = 0.217).

Patients with complex/combined procedures spent, on average, significantly more days in the ICU compared with other patients (6.5 [0.8-11.1] days v 2.0 [1.62-3.39] days; p < 0.001). Patients with heart failure spent a significantly greater number of days in the ICU compared with other patients (4.2 [2.39-7.54] days v 1.8 [1.46-2.19] days; p = 0.007).

Patients with documented preoperative hypotension spent an average of 12 (5.88-18.12) days in the hospital compared with 6.5 (5.55-9.04) days for other patients (p < 0.001). Patients experiencing a myocardial infarction within 5 days of the procedure spent, on average, 9.6 (7.42-13.91) days in the hospital compared with 6.5 (5.28-9.03) days for other patients (p = 0.002).

In general, fenoldopam was well tolerated, and no significant adverse events specifically attributable to the drug were noted. Nineteen patients (27%) developed atrial fibrillation in the postoperative period. Three other patients (4%) developed other arrhythmias requiring therapy.

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Discussion 

In this study, only 7.1% (5/70) developed non–dialysis-dependent renal dysfunction, subsequent to an infusion of low-dose fenoldopam (0.03 μg/kg/min). If this is compared with a multicenter study of cardiac surgery that was undertaken before the release of fenoldopam,1 patients in this current study tended to have lower incidences of postoperative renal dysfunction. In the reference study,1 patients with one risk factor had a 7.7% incidence versus 3.6% incidence in the present study, whereas those with 2 or more risk factors had a 19% versus 9.5% incidence. With the exception of preoperative serum creatinine ≥1.4 mg/dL as a risk factor, the proportion of patients with each of the individual, previously defined, risk factors who developed non–dialysis-dependent renal dysfunction in the current study was lower than in the reference study (Table 2). These findings are suggestive of a possible renoprotective role for low-dose fenoldopam in patients considered to be at high risk of renal dysfunction after cardiac surgery using recognized risk assessment profiling.1

Although it is generally accepted that the higher the number of risk factors, the greater the risk of developing renal dysfunction, it is interesting to note that of the 6 patients with all 4 risk factors, none developed non–dialysis-dependent renal dysfunction. Furthermore, diabetes is a recognized risk factor for renal dysfunction irrespective of the clinical setting; in this study, only 2 of the 31 patients with non–insulin-dependent diabetes developed non–dialysis-dependent renal dysfunction subsequent to an infusion of fenoldopam.

In agreement with many other studies of post–cardiac surgery renal function, the mean postoperative serum creatinine rose to a peak on the second or third postoperative day and was significantly higher than the preoperative baseline value. However, it then decreased to a level that was significantly lower than the baseline value (1.16 ± 0.36 mg/dL v 1.26 ± 0.34 mg/dL). This may not be clinically relevant. Preliminary reports of small decrements in renal function after cardiac surgery have been associated with prolonged hospitalization27; it is not known whether small improvements in renal function confer beneficial effects in this context.

Fenoldopam was generally well tolerated; however, 27% (19/70) of the patients developed atrial fibrillation, whereas another 4% (3/70) developed other arrhythmias requiring treatment. In recognizing that arrhythmias have been associated with the use of the parent drug dopamine,28 an association between fenoldopam and arrhythmias cannot be ruled out. However, the rate of arrhythmias that occurred in this study is also within the reported range for postoperative cardiac patients irrespective of medications29, 30; it is also noteworthy that arrhythmia is not an adverse event associated with higher dose fenoldopam.23, 24, 25, 26, 31, 32

In presenting these findings, the limitations of the study should be considered. This was a single-center observational study undertaken by a single anesthesiologist, the results of which are compared with a large multicenter trial from the early 1990s. It was not designed to examine the causes of renal dysfunction or to provide long-term follow-up data; as such, these data offer a representative snapshot of the particularly critical perioperative period.

Although postoperative serum creatinine levels are indicative of a trend toward developing renal dysfunction, serum creatinine values often normalize gradually in many patients; elevated creatinine levels do not necessarily correspond to permanent renal dysfunction. Furthermore, renal dysfunction may arise from relatively subtle changes in creatinine levels in this patient population, and, therefore, relating absolute values to changes in renal function should be done with caution. In large-scale trials, however, both postoperative serum creatinine and changes in creatinine clearance have been shown to be associated with morbidity and mortality.1, 2

The results from this study are interesting. However, the evidence for the efficacy of fenoldopam in patients at risk for renal dysfunction after cardiac surgery is relatively weak because there is no randomized controlled study. Given the paucity of firm supporting data for any of the renal protective agents in current routine use, a randomized control trial of fenoldopam in cardiac surgery is required to prove whether it may have a renal protection role.

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☆ Address reprint requests to Susan Garwood, MB, ChB, Department of Anesthesiology, Yale University School of Medicine, 333 Cedar Street, PO Box 208051, New Haven, CT 06520-8051. E-mail: susan.garwood@yale.edu

PII: S1053-0770(02)47705-1

doi:10.1053/jcan.2003.5

Journal of Cardiothoracic and Vascular Anesthesia
Volume 17, Issue 1 , Pages 17-21, February 2003

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