NCT00953940

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 4, 2011

Status Verified

August 1, 2009

Enrollment Period

5.7 years

First QC Date

August 4, 2009

Last Update Submit

June 30, 2011

Conditions

Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

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

    5 years

Study Arms (2)

Isotonic saline

EXPERIMENTAL

Isotonic saline

Drug: Isotonic saline

No treatment

NO INTERVENTION

Habitual therapy

Interventions

Isotonic salineDRUG

Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery

Isotonic saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26825017DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Dr Fernando Liaño, MD PhD

    Hospital Universitario Ramon y Cajal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

June 1, 2005

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

July 4, 2011

Record last verified: 2009-08

Locations

ES(1)