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CompletedNCT01218828POSEIDONUpdated Mar 11, 2015

Prevention of Contrast Renal Injury With Different Hydration Strategies

A Phase 3 interventional study of LVEDP -Based hydration strategy and Standard hydration in Contrast Medium-induced Nephropathy, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-11.

Sponsored by Kaiser Permanente · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
396
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

Subjects will be randomized to one of two hydration protocols:

  1. 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.
  2. 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.

02

Conditions studied

  • Contrast Medium-induced Nephropathy

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Keywords

  • Contrast
  • nephropathy
  • cardiac catheterization
  • angiography
  • percutaneous coronary intervention is
03

In context

Kidney Diseases

3,843 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.

This study's enrollment of 396 is above the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Kaiser Permanente is the lead sponsor of 392 studies on the registry; 42 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
396 participants (actual)

Study arms

  • Active comparator
    Standard therapy

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

    Other: Standard hydration

  • Experimental
    LVEDP-based hydration strategy

    LVEDP guided hydration with 0.9% saline (treatment group)

    Other: LVEDP -Based hydration strategy

Interventions

  • OtherLVEDP -Based hydration strategy
  • OtherStandard hydration
06

What researchers measure

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

07

Study locations

1 site
  • Kaiser Permanente
    Los Angeles, California 90027, United States
08

References and documents

Publications

  • 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. PubMed 24856027 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Aug 2012 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2010
First posted
Oct 11, 2010
Start
Oct 2010
Primary completionActual
Aug 2012
CompletionActual
Jan 2013
Last update
Mar 11, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01218828
Lead sponsor
Kaiser Permanente
Responsible party
Sponsor
First posted
Oct 11, 2010
Start date
Oct 2010
Primary completion
Aug 2012
Completion
Jan 2013
Last update
Mar 11, 2015

Study contacts

Somjot S Brar, MD
principal investigator · Kaiser Permanente

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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