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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:
ClinicalTrials.gov Identifier:
NCT00953940
First Posted: August 6, 2009
Last Update Posted: July 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitario Ramon y Cajal
August 4, 2009
August 6, 2009
July 4, 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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Serrano AB, Candela-Toha AM, Zamora J, Vera J, Muriel A, Del Rey JM, Liaño 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.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00953940
Nefrane001
NºEudra CT: 2005-004755-35
No
Not Provided
Not Provided
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