Prevention of Perioperative Acute Renal Failure | NCT00953940

Studies
Prevention of Perioperative Acute Renal Failure

NCT00953940

Sponsor

Hospital Universitario Ramon y Cajal

Status

Terminated

Last Update Posted

Jul 4, 2011Estimated

Enrollment

600Estimated

Phase

Phase 4

Conditions

Abdominal Surgery

Interventions

Isotonic saline

Countries

Spain

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

ID	Type	Description	Link
NºEudra CT: 2005-004755-35

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

An external board recommended to close the study for futility after the interin analysis

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Feb 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Aug 4, 2009

First Submission Date that Met QC Criteria

Aug 5, 2009

First Posted Date

Aug 6, 2009Estimated

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

Jun 30, 2011

Last Update Posted Date

Jul 4, 2011Estimated

Name	Class
Fondo de Investigacion Sanitaria	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isotonic saline	Experimental	Isotonic saline	Drug: Isotonic saline
No treatment	No Intervention	Habitual therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isotonic saline	Drug	Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery	Isotonic saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery.		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who are undergoing elective abdominal surgery after appropriate information of the study, and its possible risks that may arise therefrom and that at any time to refuse their cooperation, give a written consent to participate in the study.
Patients who at the time of the interview have an ASA between 2 and 4.
Patients with chronic kidney failure mild moderate (serum creatinine between 1.5 and 3.0 mg / dl) can be included.

Exclusion Criteria:

Chronic kidney diseases with serum creatinine higher than 3.0 mg /DL
Laparoscopic abdominal surgery
ASA 1 and ASA 5 patients.
Patients with cardiac insufficiency, ascites and respiratory insufficiency
Diastolic hypertension > 100 mmHg

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
Dr Fernando Liaño, MD PhD	Hospital Universitario Ramon y Cajal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Ramon y Cajal		Madrid	Madrid	28034	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26825017	Derived	Serrano AB, Candela-Toha AM, Zamora J, Vera J, Muriel A, Del Rey JM, Liano F. Preoperative hydration with 0.9% normal saline to prevent acute kidney injury after major elective open abdominal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jun;33(6):436-43. doi: 10.1097/EJA.0000000000000421.

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals