Background Injections of radiocontrast agents are a frequentcause of acute decreases in renal function, occurring most oftenin patients with chronic renal insufficiency and diabetes mellitus.
Methods We prospectively studied 78 patients with chronic renalinsufficiency (mean [±SD] serum creatinine concentration,2.1 ±0.6 mg per deciliter [186 ±53 µmolper liter]) who underwent cardiac angiography. The patientswere randomly assigned to receive 0.45 percent saline alonefor 12 hours before and 12 hours after angiography, saline plusmannitol, or saline plus furosemide. The mannitol and furosemidewere given just before angiography. Serum creatinine was measuredbefore and for 48 hours after angiography, and urine was collectedfor 24 hours after angiography. An acute radiocontrast-induceddecrease in renal function was defined as an increase in thebase-line serum creatinine concentration of at least 0.5 mgper deciliter (44 µmol per liter) within 48 hours afterthe injection of radiocontrast agents.
Results Twenty of the 78 patients (26 percent) had an increasein the serum creatinine concentration of at least 0.5 mg perdeciliter after angiography. Among the 28 patients in the salinegroup, 3 (11 percent) had such an increase in serum creatinine,as compared with 7 of 25 in the mannitol group (28 percent)and 10 of 25 in the furosemide group (40 percent) (P = 0.05).The mean increase in serum creatinine 48 hours after angiographywas significantly greater in the furosemide group (P = 0.01)than in the saline group.
Conclusions In patients with chronic renal insufficiency whoare undergoing cardiac angiography, hydration with 0.45 percentsaline provides better protection against acute decreases inrenal function induced by radiocontrast agents than does hydrationwith 0.45 percent saline plus mannitol or furosemide.
Acute decreases in renal function induced by the administrationof radiocontrast agents are an important cause of hospital-acquiredrenal insufficiency, which contributes to morbidity and mortalityduring hospitalization and to the incidence of chronic end-stagerenal disease1,2,3,4. Although the pathogenesis of acute renalinsufficiency induced by radiocontrast agents is not fully understood,it appears to be due to medullary ischemia caused by decreasedrenal blood flow resulting from an imbalance of vasodilativeand vasoconstrictive factors5. Because procedures involvingthe use of radiocontrast agents are scheduled beforehand andtheir occurrence is therefore predictable, a variety of prophylacticapproaches have been suggested, including saline hydration andthe administration of mannitol or furosemide6. There are, however,no prospective randomized trials directly comparing these approaches.We therefore undertook to compare the prophylactic efficacyof saline hydration alone with that of saline hydration pluseither mannitol or furosemide in a group of patients at highrisk for an acute decrease in renal function induced by radiocontrastagents.
Methods
Patients
Patients scheduled for cardiac angiography who had serum creatinineconcentrations exceeding 1.6 mg per deciliter (140 µmolper liter) or rates of creatinine clearance below 60 ml perminute (<1.0 ml per second), calculated on the basis of serumcreatinine concentration, weight, age, and sex,7 were eligiblefor the study. The indications for angiography were determinedby each patient's cardiologist. Most patients were studied becauseof symptomatic coronary ischemia. The choice of radiocontrastagent was also made by the cardiologist. There were no differencesin the types of radiocontrast agents used in the three treatmentgroups. Of the 78 patients enrolled in the study, 25 (32 percent)received ionic, high-osmolality radiocontrast agents, and theremainder received ionic, low-osmolality or non-ionic, low-osmolalityradiocontrast agents (32 percent and 35 percent, respectively).The protocol was approved by the Committee on Human Researchof New England Deaconess Hospital, and all patients gave writteninformed consent.
Study Protocol
All the patients received 0.45 percent saline intravenouslyat a rate of 1 ml per kilogram of body weight per hour beginning12 hours before the scheduled angiography. This saline infusionwas continued during the angiography (saline group) or was supplementedwith 25 g of mannitol, infused intravenously during the 60 minutesimmediately before angiography (mannitol group), or with 80mg of furosemide, infused intravenously during the 30 minutesimmediately before angiography (furosemide group). A hospitalpharmacist who had no knowledge of the patients assigned eachpatient to one of the three groups using a random-allocationtable. All the patients continued to receive 0.45 percent salineintravenously at the same rate for 12 hours after angiographyand were encouraged to drink if thirsty. Serum creatinine andblood urea nitrogen were measured 12 to 24 hours before angiography,at the time of angiography, and on the next two mornings (i.e.,24 and 48 hours later). Urine was collected for the first 24hours after angiography. Urinary sodium and potassium were measuredby flame photometry, and creatinine by AutoAnalyzer. A radiocontrast-induceddecrease in renal function was defined as an increase in thebase-line serum creatinine concentration of at least 0.5 mgper deciliter ( 44 µmol per liter) within 48 hours afterthe injection of radiocontrast medium.
Statistical Analysis
Continuous variables were analyzed by analysis of variance,and categorical variables by the chi-square test. Analyses indicatingsignificant differences among the three treatment groups werefollowed by two-tailed pairwise analyses with the t-test forcontinuous variables and Fisher's exact test for categoricalvariables. Data are expressed as means ±SD. All analyseswere performed with Systat (version 5.1, Systat, Evanston, Ill.).
Results
A total of 78 patients were enrolled, and all completed theprotocol. Their demographic characteristics are shown in Table 1.The number of patients with diabetes mellitus or congestiveheart failure was similar in each of the three groups, as wasthe number receiving diuretics or calcium-channel antagonistsbefore angiography. The volume of radiocontrast agent and thetotal dose of iodine given in the three groups were also similar.
Table 1. Demographic Characteristics of the Patients with Chronic Renal Insufficiency in the Three Treatment Groups.
The changes in the serum creatinine concentration of each patientare shown in Figure 1. The mean serum creatinine concentrationat the time the radiocontrast agents were administered was similarin each treatment group. The increase in the serum creatinineconcentration was significantly greater 24 hours after angiographyin the mannitol group (P = 0.01) and the furosemide group (P= 0.02) than in the saline group, and was also significantlygreater 48 hours after angiography in the furosemide group (P= 0.01) (Table 2). The serum creatinine concentration increasedby at least 0.5 mg per deciliter in 20 of the 78 patients (26percent): 3 of the 28 patients who received saline (11 percent),7 of the 25 patients who received mannitol (28 percent), and10 of the 25 patients who received furosemide (40 percent, P= 0.02 for the comparison with the saline group alone). Therewas no significant difference between the mannitol and furosemidegroups. When the prehydration serum creatinine concentrationwas used to estimate the incidence of radiocontrast-inducedincreases in serum creatinine, there was still a significantdifference between the saline group and the furosemide group(7 percent and 32 percent, respectively; P = 0.02). Increasesin the serum creatinine concentration were not limited to patientswith the most severe chronic renal insufficiency. When patientswith serum creatinine concentrations of at least 3.0 mg perdeciliter (265 µmol per liter) before hydration were excludedfrom the analysis, the pattern of radiocontrast-induced increasesin serum creatinine among the groups was similar: 4 percentin the saline group, 24 percent in the mannitol group, and 35percent in the furosemide group had such increases (P = 0.02for the comparison of the furosemide group with the saline group).
Figure 1. Serum Creatinine Concentrations Immediately before the Administration of Radiocontrast Agent (after 12 Hours of Hydration) and 48 Hours Later in Patients with Chronic Renal Insufficiency.
The mean (±SE) for each treatment group is indicated by the heavy lines and circles. The increase in serum creatinine was significantly greater in the furosemide group than in the saline group (P<0.01 by t-test). To convert values for serum creatinine to micromoles per liter, multiply by 88.4.
Table 2. Absolute Changes in Serum Creatinine Concentration after the Administration of Radiocontrast Agents and the Incidence of Acute Renal Dysfunction, According to Treatment Group.
The changes in weight 24 hours after angiography were similarin all three groups (Table 3). The three groups also did notdiffer significantly in the ratio of blood urea nitrogen toserum creatinine, total urinary output, or urinary sodium excretionduring the initial 24 hours after angiography. These resultssuggest that extracellular volume depletion, potentially causedby mannitol or furosemide, did not contribute to the higherincidence of acute radiocontrast-induced decreases in renalfunction in these two groups.
Table 3. Measures of Volume Status in the Three Treatment Groups.
In each treatment group, the incidence of increases in serumcreatinine was slightly but not significantly higher in thediabetic than in the nondiabetic patients (Table 4). There wereno significant differences in the incidence of decreased renalfunction between patients who received calcium-channel antagonistsand those who did not receive them in any treatment group.
Table 4. Incidence of Acute Radiocontrast-Induced Renal Dysfunction, According to Treatment Group, Diabetic Status, and Need for Therapy with Calcium-Channel Antagonists.
In patients who had increases in the serum creatinine concentration,the peak response was on day 4, and it was still above the prehydrationlevel on day 7. Although only one patient (in the furosemidegroup) required dialysis, the average length of hospitalizationfor all patients with radiocontrast-induced acute renal dysfunctionwas increased by four days.
There were too few cases of radiocontrast-induced increasesin the serum creatinine concentration to analyze the effectof radiocontrast agents independently of treatment group. Foreach of the three radiocontrast agents used in this study, moreof the patients who were treated with furosemide had acute renaldysfunction than did saline-treated patients. There were nodifferences when non-ionic and ionic radiocontrast agents werecompared with respect to the incidence of acute renal dysfunction.
Discussion
Angiography remains an important cause of hospital-acquiredacute renal insufficiency. In previous studies, the incidencevaried from 0 to 90 percent depending on the group studied.We chose to study patients with chronic renal insufficiency,many of whom also had diabetes, because they are generally consideredto be at greatest risk for renal insufficiency induced by radiocontrastagents8,9,10,11,12,13,14,15,16.
We defined an acute radiocontrast-induced decrease in renalfunction as an increase of at least 0.5 mg per deciliter inthe serum creatinine concentration within 48 hours after theadministration of radiocontrast agents. Through a questionnairesent to attending physicians before the study, we asked themto specify the minimal change in the serum creatinine concentrationafter the administration of radiocontrast agents that wouldlead to a delay in elective surgery or a follow-up procedureand thus, presumably, increase the length of hospitalization.Eighty percent of the 84 respondents reported that an increaseof 0.5 mg per deciliter after angiography would cause them todelay an elective procedure. Thus, this value represented aclinically important adverse event.
The most important finding of this study is that hydration with0.45 percent saline alone was associated with the lowest incidenceof radiocontrast-induced acute renal dysfunction in the patientsstudied. Only 11 percent of the patients who received salinealone had such a decrease in renal function. This value is lessthan that reported for similar patients in most previous studies8,11,14,15,17,18,19,20,21,22.In only one other study involving patients undergoing cardiacangiography was the incidence as low, and the hydration protocolin that study was similar to the saline treatment in our study14.Other studies have also supported the efficacy of hydrationin preventing radiocontrast-induced renal dysfunction. Among518 patients with a mean serum creatinine concentration of 1.9mg per deciliter (168 µmol per liter) who were undergoingcardiac angiography, 76 had radiocontrast-induced renal dysfunction(defined as in our study). The only significant differencesbetween these patients and a matched group of 82 patients withno changes in renal function were the volume of radiocontrastagent given, the diastolic pressure before angiography, andthe frequency of hydration in the previous 24 hours23. In anuncontrolled study of 25 patients with chronic renal insufficiency(serum creatinine concentration, >1.8 mg per deciliter [159µmol per liter]), no patient who received 550 ml of 0.9percent saline per hour during a variety of angiographic procedureshad radiocontrast-induced renal dysfunction24. Among 18 patientswith serum creatinine values above 1.7 mg per deciliter (150µmol per liter) who were randomly assigned to receivehydration (3000 ml total) or hydration plus furosemide (110mg intravenously), the group receiving hydration alone had nochange in the serum creatinine concentration at 24 hours whereasthe group receiving furosemide had an increase25. In anothergroup of patients (mean serum creatinine concentration, 2.5mg per deciliter [222 µmol per liter]), saline reducedthe incidence of radiocontrast-induced renal dysfunction inthose who had diabetes but not in those without diabetes26.The incidence of acute renal dysfunction was 40 percent in thesaline-treated group, which was similar to that in the furosemide-treatedpatients in our study.
Mannitol has been recommended for the prevention of radiocontrast-inducedacute renal dysfunction because of its efficacy in preventingor reducing the severity of ischemic renal insufficiency inhumans27,28. In uncontrolled studies, mannitol protected againstsuch renal dysfunction in patients with chronic renal insufficiencywho were undergoing angiography. In one study of patients witha mean serum creatinine concentration of 4.1 mg per deciliter(362 µmol per liter), 22 percent of 37 patients givensaline and 50 g of mannitol had radiocontrast-induced renaldysfunction, as compared with 70 percent of historical controlsgiven saline alone29. In a prospective, randomized trial of24 patients (mean serum creatinine concentration, 2.2 mg perdeciliter [194 µmol per liter]) who were undergoing amixed group of angiographic procedures, the infusion of 25 gof mannitol immediately after the administration of radiocontrastagents was beneficial, especially in those with diabetes30.Another study found no cases of radiocontrast-induced renalinsufficiency in nondiabetic patients given an infusion of 30g of mannitol during angiography26. We found no evidence thatmannitol was beneficial in either diabetic or nondiabetic patients.Finally, in another prospective trial of 60 patients with amean serum creatinine concentration of 4.2 mg per deciliter(371 µmol per liter), an infusion of 25 g of mannitolimmediately after angiography did not prevent radiocontrast-inducedrenal dysfunction31.
The use of furosemide for the prevention of radiocontrast-inducedrenal dysfunction is also controversial. In an uncontrolledstudy of 17 patients with a mean serum creatinine concentrationof 4.0 mg per deciliter (354 µmol per liter) who weregiven furosemide after infusion pyelography, the incidence ofsuch renal dysfunction was only 18 percent, as compared with70 percent in a group of historical controls32. No cases werereported in another uncontrolled study in which the patientsreceived hydration and various doses of furosemide to maintaina urinary output of 300 ml per hour33. However, in a prospective,randomized study of 18 patients with chronic renal insufficiency,pretreatment with furosemide (1.5 mg per kilogram 30 minutesbefore the administration of radiocontrast agents) was associatedwith a greater increase in serum creatinine at 24 hours thanwas hydration alone25.
We found that neither mannitol nor furosemide offered additionalprotection against acute radiocontrast-induced decreases inrenal function as compared with saline hydration alone in eitherdiabetic or nondiabetic patients. The significantly higher incidencein the furosemide group is provocative but unexplained. On thebasis of data obtained during the 24 hours after the administrationof the radiocontrast agents, furosemide did not induce volumedepletion. Indeed, furosemide was associated with a significantlygreater increase in the serum creatinine concentration at 24hours even in patients who gained weight. However, since furosemidewas given 30 minutes before the administration of radiocontrastagents, it may have caused systemic or renal hemodynamic changesthat exacerbated those produced by the radiocontrast agent itself.For example, a decrease in cortical vascular resistance coulddivert blood from the medullary circulation. In concert withradiocontrast-induced renal vasoconstriction, this may producea critical reduction in oxygen tension in the medullary nephrons,resulting in ischemic injury.
In conclusion, we found that hydration with 0.45 percent salinefor 12 hours before and 12 hours after the administration ofradiocontrast agents was the most effective means of preventingacute decreases in renal function in patients with chronic renalinsufficiency with or without diabetes mellitus. Neither mannitolnor furosemide offered any additional benefit when added tothis hydration protocol.
Supported by a grant from the Extramural Grant Program of BaxterHealthCare Corporation.
Source Information
From New England Deaconess Hospital, Joslin Diabetes Center, and Harvard Medical School -- all in Boston. Presented at the 25th Annual Meeting of the American Society of Nephrology, Baltimore, November 15-18, 1992.
Address reprint requests to Dr. Solomon at Joslin Diabetes Center, 1 Joslin Pl., Boston, MA 02215.
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44 µmol per liter) within 48 hours after the injection of radiocontrast medium. 
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