Contrast Medium-induced NephropathyPhase 3POSEIDONNCT01218828
Prevention of Contrast Renal Injury With Different Hydration Strategies
A Phase 3 study testing LVEDP -Based hydration strategy and Standard hydration in people with Contrast Medium-induced Nephropathy, run by Kaiser Permanente at 1 site in United States.
Trial summary
Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Medium-induced Nephropathy
- What is being tested?
- LVEDP -Based hydration strategy and Standard hydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial
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:
- 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.
- Conditions
- Contrast Medium-induced Nephropathy
- Being tested
- LVEDP -Based hydration strategy, Standard hydration
- Keywords
- Contrast, nephropathy, cardiac catheterization, angiography, percutaneous coronary intervention is
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVEDP -Based hydration strategyOther
Standard hydrationOther
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | Active comparator | Hydration with 0.9% saline per a standard protocol (control group) Receives: Other: Standard hydration |
| LVEDP-based hydration strategy | Experimental | LVEDP guided hydration with 0.9% saline (treatment group) Receives: Other: LVEDP -Based hydration strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy
Measured: Within four days of contrast exposure
Secondary outcomes (1)
Renal replacement therapy, myocardial infarction, all-cause mortality
Measured: 30 days and long-term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Medium-induced NephropathyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somjot S Brar, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218828
- Sponsor's protocol ID
- KP-RCCL-5718
- Acronym
- POSEIDON
- Status last verified
- Mar 2015
- First submitted
- 8 Oct 2010
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01218828
- Acronym / sponsor ID
- POSEIDON / KP-RCCL-5718
- Conditions
- Contrast Medium-induced Nephropathy
- Keywords
- Contrast, nephropathy, cardiac catheterization, angiography, percutaneous coronary intervention is
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | Active comparator | Other: Standard hydrationHydration with 0.9% saline per a standard protocol (control group) |
| LVEDP-based hydration strategy | Experimental | Other: LVEDP -Based hydration strategyLVEDP guided hydration with 0.9% saline (treatment group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVEDP -Based hydration strategy | Other | LVEDP-based hydration strategy |
| Standard hydration | Other | Standard therapy |
Primary outcome
Contrast induced nephropathy
Time frame: Within four days of contrast exposure
1 secondary outcome
Renal replacement therapy, myocardial infarction, all-cause mortality
Time frame: 30 days and long-term
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Derived from this study: PubMed 24856027Brar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somjot S Brar, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LVEDP -Based hydration strategy and Standard hydration in people with Contrast Medium-induced Nephropathy, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast induced nephropathy (time frame: Within four days of contrast exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01218828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.