Prevention of Perioperative Acute Renal Failure

This study has been terminated.
(An external board recommended to close the study for futility after the interin analysis)
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00953940
First received: August 4, 2009
Last updated: June 30, 2011
Last verified: August 2009

August 4, 2009
June 30, 2011
June 2005
February 2011   (final data collection date for primary outcome measure)
Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00953940 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of Perioperative Acute Renal Failure
Prevention of Perioperative Acute Renal Failure in Abdominal Surgery

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Abdominal Surgery
Drug: Isotonic saline
Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery
  • Experimental: Isotonic saline
    Isotonic saline
    Intervention: Drug: Isotonic saline
  • No Intervention: No treatment
    Habitual therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
May 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00953940
Nefrane001, NºEudra CT: 2005-004755-35
No
Fernando Liaño García, Hospital Universitario Ramon y Cajal
Hospital Universitario Ramon y Cajal
Fondo de Investigacion Sanitaria
Principal Investigator: Dr Fernando Liaño, MD PhD Hospital Universitario Ramon y Cajal
Hospital Universitario Ramon y Cajal
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP