Prevention of Contrast Renal Injury With Different Hydrat... | NCT01218828

Studies
Prevention of Contrast Renal Injury With Different Hydration Strategies

NCT01218828

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Mar 11, 2015Estimated

Enrollment

396Actual

Phase

Phase 3

Conditions

Contrast Medium-induced Nephropathy

Interventions

LVEDP -Based hydration strategy
Standard hydration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Aug 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Oct 8, 2010

First Submission Date that Met QC Criteria

Oct 8, 2010

First Posted Date

Oct 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2015

Last Update Posted Date

Mar 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

396Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard therapy	Active Comparator	Hydration with 0.9% saline per a standard protocol (control group)	Other: Standard hydration
LVEDP-based hydration strategy	Experimental	LVEDP guided hydration with 0.9% saline (treatment group)	Other: LVEDP -Based hydration strategy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LVEDP -Based hydration strategy	Other		LVEDP-based hydration strategy
Standard hydration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contrast induced nephropathy		Within four days of contrast exposure

Secondary Outcomes

Measure	Description	Time Frame
Renal replacement therapy, myocardial infarction, all-cause mortality		30 days and long-term

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Somjot S Brar, MD	Kaiser Permanente	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente		Los Angeles	California	90027	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24856027	Derived	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.

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases