NCT00254150

Brief Summary

Postoperative organ failures commonly occur after major abdominal surgery and substantially increase the utilization of resources and the costs of care, and are favored by tissue hypoxia. A therapeutic strategy designed to detect and reverse tissue hypoxia, as diagnosed by an increase of oxygen extraction over a pre-defined threshold could decrease the incidence of organ failures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1995

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 1995

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1996

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
Last Updated

November 15, 2005

Status Verified

April 1, 1995

First QC Date

November 14, 2005

Last Update Submit

November 14, 2005

Conditions

High-Risk Surgical Patients

Outcome Measures

Primary Outcomes (1)

  • reduction of patients with postoperative organ failure

Secondary Outcomes (1)

  • reduction of length of hospital stay

Interventions

Increase oxygen extraction ratePROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • high risk surgical patients requiring major abdomina surgery

You may not qualify if:

  • age below 16 years, preexistent neurologic, or malignant haematologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Umberto I - U.O. Anestesia e Rianimazione Clinica

Ancona, Ancona, 60020, Italy

Location

Related Publications (1)

  • Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.

    PMID: 17925428DERIVED

Study Officials

  • Paolo Pietropaoli, MD

    Università La Sapienza, Roma - Istituto di Anestesia e Rianimazione

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 15, 2005

Study Start

May 1, 1995

Study Completion

December 1, 1996

Last Updated

November 15, 2005

Record last verified: 1995-04

Locations

IT(1)