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

Primary Purpose

Contrast Medium-induced Nephropathy

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

LVEDP -Based hydration strategy

Standard hydration

About this trial

This is an interventional prevention trial for Contrast Medium-induced Nephropathy focused on measuring Contrast, nephropathy, cardiac catheterization, angiography, percutaneous coronary intervention is

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaiser Permanente

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard therapy

LVEDP-based hydration strategy

Arm Description

Hydration with 0.9% saline per a standard protocol (control group)

LVEDP guided hydration with 0.9% saline (treatment group)

Outcomes

Primary Outcome Measures

Contrast induced nephropathy

Secondary Outcome Measures

Renal replacement therapy, myocardial infarction, all-cause mortality

Full Information

NCT ID

NCT01218828

First Posted

October 8, 2010

Last Updated

March 10, 2015

Sponsor

Kaiser Permanente

1. Study Identification

Unique Protocol Identification Number

NCT01218828

Brief Title

Prevention of Contrast Renal Injury With Different Hydration Strategies

Acronym

POSEIDON

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contrast Medium-induced Nephropathy

Keywords

Contrast, nephropathy, cardiac catheterization, angiography, percutaneous coronary intervention is

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

396 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard therapy

Arm Type

Active Comparator

Arm Description

Hydration with 0.9% saline per a standard protocol (control group)

Arm Title

LVEDP-based hydration strategy

Arm Type

Experimental

Arm Description

LVEDP guided hydration with 0.9% saline (treatment group)

Intervention Type

Other

Intervention Name(s)

LVEDP -Based hydration strategy

Intervention Type

Other

Intervention Name(s)

Standard hydration

Primary Outcome Measure Information:

Title

Contrast induced nephropathy

Time Frame

Within four days of contrast exposure

Secondary Outcome Measure Information:

Title

Renal replacement therapy, myocardial infarction, all-cause mortality

Time Frame

30 days and long-term

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Somjot S Brar, MD

Organizational Affiliation

Kaiser Permanente

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24856027

Citation

Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.

Results Reference

derived

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Prevention of Contrast Renal Injury With Different Hydration Strategies

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