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Preoperative Hyperthermia in Major Abdominal Surgery Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Braun Stiftung
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00876954
First received: April 6, 2009
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Fever
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Estimated Enrollment: 20
Study Start Date: April 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Warming without increase in core temperature
 Procedure: Normothermia
Warming without increase in core temperature
Active Comparator: Hyperthermia
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: Oliver Kimberger, M.D., Medical University of Vienna, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00876954     History of Changes
Other Study ID Numbers: PreopHypertherm1
Study First Received: April 6, 2009
Last Updated: July 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013