Prevention of Contrast Renal Injury With Different Hydration Strategies - POSEIDON (Prevention of Contrast Renal Injury)

Jun 30, 2014
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Kaiser Permanente Southern California
Date Presented:
01/01/2012
Date Published:
01/01/2014
Date Updated:
06/30/2014
Original Posted Date:
06/30/2014
References

Description:

Although intravenous hydration is routinely used to prevent contrast-induced hydration in patients undergoing cardiac catheterization, the optimal amount and duration are not defined. The current trial sought to compare intravenous hydration based on left ventricular end-diastolic pressure (LVEDP) guidance with routine hydration in patients with chronic kidney disease (CKD) undergoing cardiac catheterization.

Hypothesis:

LVEDP-guided hydration would be superior to routine hydration in patients with CKD undergoing cardiac catheterization.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Estimated GFR <60 ml/min/1.73 m2 (based on Modification of Diet in Renal Disease [MDRD])
  • At least one of the following: diabetes mellitus, age >75 years, hypertension, or history of CHF

    Number of screened applicants: 1,594
    Number of enrollees: 396
    Duration of follow-up: 30 days
    Mean patient age: 71.5 years
    Percentage female: 39%
    New York Heart Association class: 56.5%

Exclusions:

  • Pulmonary edema or acute decompensated heart failure
  • Contrast exposure within 48 hours
  • Severe valvular heart disease or mechanical aortic valve
  • Heart or kidney transplant status
  • Primary PCI
  • >15% change in serum creatinine in the previous 2 days

Primary Endpoints:

  • 25% or 0.5 mg/dl increase in serum creatinine (at least two values measured on days 1-4)

Secondary Endpoints:

  • 30-day major adverse event (death, myocardial infarction, and dialysis)

Drug/Procedures Used:

Patients with CKD were randomized in a 1:1 fashion to either LVEDP-guided hydration or routine hydration. LVEDP was measured prior to contrast administration. All patients received normal saline (NS) at 3 ml/kg for 1 hour before the procedure. In the LVEDP-guided hydration arm, a sliding-scale hydration was employed based on LVEDP: 5 ml/kg/hr for LVEDP <13 mm Hg, 3 ml/kg/hr for LVEDP 13-18 mm Hg, and >1.5 ml/kg/hr for LVEDP >18 mm Hg. The routine hydration arm received NS at 1.5 ml/kg/hr. All patients received hydration for 4 hours following the procedure.

Concomitant Medications:

Ioxilan was used as the contrast agent of choice for all patients. Angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers: 79%, loop diuretics 23.5%, thiazide diuretics 20%, N-acetylcysteine (NAC) 38%.

Principal Findings:

A total of 392 patients were randomized, 196 to LVEDP-guided hydration and 200 to standard hydration. Baseline characteristics were fairly similar between the two arms. Approximately 52% had diabetes, 11% had congestive heart failure (CHF), 98% had hypertension, and 28% underwent percutaneous coronary intervention (PCI). The mean baseline serum creatinine was 1.4 mg/dl with a mean estimated glomerular filtration rate (eGFR) of 47.5 ml/min. The mean LVEDP was 12 mm Hg; 85% had an LVEDP ≤18%. The mean contrast volume used was approximately 108 cc. The median NS volume was higher in the LVEDP-guided hydration arm (1,727 ml vs. 812 ml, p < 0.001).

The primary endpoint of contrast-induced nephropathy was significantly lower in the LVEDP-guided hydration arm as compared with the routine hydration arm (6.7% vs. 16.3%, relative risk 0.41, 95% confidence interval 0.22-0.79, p = 0.005). This was driven mostly by a lower risk of >25% increase in serum creatinine in the LVEDP-guided hydration arm (6.7% vs. 15.7%, p = 0.008); outcomes based on a 0.5 mg/dl increase in serum creatinine were similar (2.8% vs. 6.4%, p = 0.13). In patients with GFR <45, the incidence of contrast-induced nephropathy was similarly reduced (8% vs. 23%, p = 0.03). No differences were noted among patients who also received NAC, or those who received >100 ml of contrast. 

The 30-day composite major adverse event endpoint was numerically lower in the LVEDP-guided hydration arm (1.0% vs. 4%, p = 0.11). Need for dialysis at 6 months was similar (0.5% vs. 2.0%, p = 0.37). Intravenous hydration had to be terminated due to shortness of breath in three patients in each arm, and two patients required administration of an intravenous diuretic.

Interpretation:

The results of the POSEIDON trial indicate that sliding-scale intravenous hydration based on preprocedure LVEDP measurement is superior to routine hydration in patients with CKD and at high risk for development of contrast-induced nephropathy (CIN). This protocol is relatively easy to implement and therefore appealing, but needs to be studied in a larger multicenter setting for further validation. Numerous trials have studied the utility of agents such as HCO3 and NAC in patients at high risk for CIN, but results have often been mixed. Other strategies (such as hydration matched to urine output and preemptive hemodialysis in patients with very advanced CKD) are currently being evaluated.

References:

Brar SS, Aharonian V, Mansukhani P, et al. Haemodynamic-Guided Fluid Administration for the Prevention of Contrast-Induced Acute Kidney Injury: The POSEIDON Randomised Controlled Trial. Lancet 2014;383:1814-23.

Editorial: Briguori C, Condorelli G. Hydration in Contrast-Induced Acute Kidney Injury. Lancet 2014;383:1786-8.

Presented by Dr. Somjot Brar at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2012), Miami, FL, October 25, 2012.

Keywords: Risk, Follow-Up Studies, Kidney Function Tests, Cardiac Catheterization, Diuretics, Creatinine, Dyspnea, Percutaneous Coronary Intervention, Renal Dialysis, Heart Failure, Glomerular Filtration Rate, Diet, Confidence Intervals, Hypertension, Diabetes Mellitus, Renal Insufficiency, Chronic


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