Therapy Low-dose dopamine in patients with early renal dysfunction: a placebo-controlled randomised trial
This review may be edited
Summary
Posted By:	Anthony Delaney
E-Mail:	apdelane@doh.health.nsw.gov.au
Posted Date:	11/02/03
Title:	Low-dose dopamine in patients with early renal dysfunction: a placebo-controlled randomised trial
Authors:	Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group*
Reference:	Lancet 2000; 356: 2139-43
Link:	Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract:	Background Low-dose dopamine is commonly administered to critically ill patients in the belief that it reduces the risk of renal failure by increasing renal blood flow. However, these effects have not been established in a large randomised controlled trial, and use of dopamine remains controversial. We have done a multicentre, randomised, double-blind, placebo-controlled study of low-dose dopamine in patients with at least two criteria for the systemic inflammatory response syndrome and clinical evidence of early renal dysfunction (oliguria or increase in serum creatinine concentration). Methods 328 patients admitted to 23 participating intensive-care units (ICUs) were randomly assigned a continuous intravenous infusion of low-dose dopamine (2 µg kg-1 min-1) or placebo administered through a central venous catheter while in the ICU. The primary endpoint was the peak serum creatinine concentration during the infusion. Analyses excluded four patients with major protocol violations. Findings The groups assigned dopamine (n=161) and placebo (n=163) were similar in terms of baseline characteristics, renal function, and duration of trial infusion. There was no difference between the dopamine and placebo groups in peak serum creatinine concentration during treatment (245 [SD 144] vs 249 [147] µmol/L; p=0·93), in the increase from baseline to highest value during treatment (62 [107] vs 66 [108] µmol/L; p=0·82), or in the numbers of patients whose serum creatinine concentration exceeded 300 µmol/L (56 vs 56; p=0·92) or who required renal replacement therapy (35 vs 40; p=0·55). Durations of ICU stay (13 [14] vs 14 [15] days; p=0·67) and of hospital stay (29 [27] vs 33 [39] days; p=0·29) were also similar. There were 69 deaths in the dopamine group and 66 in the placebo group. Interpretation Administration of low-dose dopamine by continuous intravenous infusion to critically ill patients at risk of renal failure does not confer clinically significant protection from renal dysfunction.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
	Yes, the patients were randomly assigned in blocks of 10, stratified according to centre, by a centralised masked-draw system.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
	All patients were followed up for the primary outcome measure (peak serum creatinine). There is no mention of loss of follow-up for the other secondary outcome measures.
2b. Were patients analyzed in the groups to which they were randomized?
	There were 4 patients who were not ananlysed in the groups to which they were randomised, which are accounted for in figure 1 (2 for incorrect enrollment, one withdrew consent and 1 patient received both trial dopamine and placebo)
3. Were patients, health workers, and study personnel blind to treatment?
	Yes, a great effort was put into the blinding of the patients, healthcare workers and those assessing outcome.
4. Were the groups similar at the start of the trial?
	Yes, there were no significant differences between the 2 groups at baseline.
5. Aside from the experimental intervention, were the groups treated equally?
	There is no mention of any systematic difference between the 2 groups' treatment.
What are the Results?
1. How large was the treatment effect?
	There was no significant difference between the peak serum creatinine for the patients that received dopamine (245 umol/L) compared to those that received placebo (249 umol/L).
2. How precise was the estimate of the treatment effect?
	The sample size calculation estimated that with the 328 enrolled patients there was a 90% power to detect a 25% difference between the 2 groups with 95% certainty. [The above interpretation is based on a post-hoc power calculation. The 95% confidence intervals for the primary, and most important secondary outcomes, reveal that low-dose dopamine could: Decrease creatinine by 35.9 umol/L or increase creatinine by 27.9umol/L; Decrease the need for RRT by 12% or increase the need for RRT by 6%. Decrease mortality by 8% or increase mortality by 12%. The confidence intervals surrounding RRT and mortality do not rule out a clinically important improvement. - gord]
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
	Acute renal dysfunction associated with SIRS (Systemic Inflammatory Response Syndrome) is a common ICU problem. A wide variety of medical and surgical patients were included. As such the results of this trial are likely to be widely applicable in the ICU setting. It should be noted that none of the patients had renal dysfunction due to obstruction or intrinsic renal disease.
2. Were all clinically important outcomes considered?
	A wide variety of secondary outcomes were looked at including the use of renal replacement therapy, ICU and hospital length of stay, ICU and hospital mortality and time to recovery of renal function. No difference was found between the two groups in any of these measures. The rates of cardiac dysrythmias was similar in the 2 groups. Other complications of therapy were not mentioned.
3. Are the likely treatment benefits worth the potential harms and costs?
	As renal dose dopamine does not protect patients who are at high risk of acute renal dysfunction in the setting of SIRS from a decline in renal function, it should no longer be considered routine therapy in these patients.
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