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Prevention of Perioperative Acute Renal Failure

Primary Purpose

Abdominal Surgery

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Isotonic saline
Sponsored by
Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Ramon y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Isotonic saline

No treatment

Arm Description

Isotonic saline

Habitual therapy

Outcomes

Primary Outcome Measures

Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2009
Last Updated
June 30, 2011
Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Fondo de Investigacion Sanitaria
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1. Study Identification

Unique Protocol Identification Number
NCT00953940
Brief Title
Prevention of Perioperative Acute Renal Failure
Official Title
Prevention of Perioperative Acute Renal Failure in Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
An external board recommended to close the study for futility after the interin analysis
Study Start Date
June 2005 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isotonic saline
Arm Type
Experimental
Arm Description
Isotonic saline
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Habitual therapy
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery
Primary Outcome Measure Information:
Title
Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Fernando Liaño, MD PhD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26825017
Citation
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.
Results Reference
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Prevention of Perioperative Acute Renal Failure

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