Preoperative Hyperthermia in Major Abdominal Surgery Patients

This study is currently recruiting participants.

Verified by Medical University of Vienna, April 2009

First Received: April 6, 2009 No Changes Posted

Sponsors and Collaborators:	Medical University of Vienna Braun Stiftung
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00876954

Purpose

The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Condition	Intervention	Phase
Major Abdominal Surgery	Procedure: Normothermia Procedure: Hyperthermia	Phase I Phase II

MedlinePlus related topics: Fever Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study

Further study details as provided by Medical University of Vienna:

Estimated Enrollment:	20
Study Start Date:	April 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Warming without increase in core temperature	Procedure: Normothermia Warming without increase in core temperature
Hyperthermia: Active Comparator Hyperthermia for 2,5 hours (39 °C core temperature)	Procedure: Hyperthermia Core hyperthermia (39 °C) for 2,5 hours

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients, age 18 - 75
Open abdominal, curative cancer surgery > 2 h

Exclusion Criteria:

Pregnancy
Chronic cortisone treatment
Ongoing chemotherapy
Acute infections, septic surgery
Palliative surgery (e.g. debulking only)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876954

Contacts

Contact: Oliver Kimberger, M.D.

+4340400 ext 4107

study@kimberger.at

Locations

Austria
Oliver Kimberger M.D.	Recruiting
Vienna, Austria, 1090
Contact: Oliver Kimberger, M.D. +4340400 ext 4107 study@kimberger.at
Principal Investigator: Oliver Kimberger, M.D.

Sponsors and Collaborators

Medical University of Vienna

Braun Stiftung

Investigators

Principal Investigator:

Oliver Kimberger, M.D.

Medical University of Vienna

More Information

No publications provided

Responsible Party:	Medical University of Vienna, Department of Anesthesiology ( Oliver Kimberger, M.D. )
Study ID Numbers:	PreopHypertherm1
Study First Received:	April 6, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00876954 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Fever

ClinicalTrials.gov processed this record on May 07, 2009