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OpenTrials
Completed

NCT Number: NCT01218828

Prevention of Contrast Renal Injury With Different Hydration Strategies

Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaiser Permanente

Los Angeles, California, 90027, United States

About this study

The study population will be recruited from subjects undergoing cardiac catheterization.

Subjects will be randomized to one of two hydration protocols:

  • normal saline at 3 mL/kg for one hour prior to contrast exposure and 1.5 mL/kg/hr during and for four hours post procedure.
  • normal saline at 3 mL/kg for one hour prior to contrast exposure and then the fluid rate would be adjusted according to the left ventricular end diastolic pressure (LVEDP). The fluid rate based upon the LVEDP measurement is maintained during the procedure and for four hours post procedure. The LVEDP hydration strategy follows: (2A) < 13 mmHg, 5 mL/kg/hr during and for four hours post procedure. (2B) 13-18 mmHg, 3 mL/kg during and for four hours post procedure. (2C) > 18 mmHg, 1.5 mL/kg during and four hours post procedure.

Renal function assessment will be made using standard laboratory measures post procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • estimated GFR less than or equal to 60 mL/min/1.73 m^2
  • age greater than 18 years
  • at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension, or age greater than 75 years.

Exclusion criteria

  • patients unable to give consent
  • undergoing emergency cardiac catheterization
  • on renal replacement therapy
  • exposure to contrast media within the prior two days
  • pulmonary edema or active congestive heart failure
  • kidney transplant status
  • severe valvular abnormalities
  • change in serum creatinine greater than 15% over the prior two days

Treatment and study plan

LVEDP -Based hydration strategy

Other

Standard Hydration

Other

Primary outcomes

  1. Contrast induced nephropathy

    Time frame: Within four days of contrast exposure

Secondary outcomes

  1. Renal replacement therapy, myocardial infarction, all-cause mortality

    Time frame: 30 days and long-term

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial

Acronym: POSEIDON

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 11, 2010
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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