Prevention of Contrast Renal Injury With Different Hydration Strategies
POSEIDON
Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial
1 other identifier
interventional
396
1 country
1
Brief Summary
Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 11, 2015
March 1, 2015
1.8 years
October 8, 2010
March 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contrast induced nephropathy
Within four days of contrast exposure
Secondary Outcomes (1)
Renal replacement therapy, myocardial infarction, all-cause mortality
30 days and long-term
Study Arms (2)
Standard therapy
ACTIVE COMPARATORHydration with 0.9% saline per a standard protocol (control group)
LVEDP-based hydration strategy
EXPERIMENTALLVEDP guided hydration with 0.9% saline (treatment group)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaiser Permanente
Los Angeles, California, 90027, United States
Related Publications (1)
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.
PMID: 24856027DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Somjot S Brar, MD
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 11, 2010
Study Start
October 1, 2010
Primary Completion
August 1, 2012
Study Completion
January 1, 2013
Last Updated
March 11, 2015
Record last verified: 2015-03