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Preoperative Hyperthermia in Major Abdominal Surgery Patients

This study has been completed.
Sponsor:
Collaborator:
Braun Stiftung
Information provided by (Responsible Party):
Oliver Kimberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00876954
First received: April 6, 2009
Last updated: January 20, 2016
Last verified: January 2016
  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
Colon Cancer
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:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Immune Status [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    LPS induced TNF-alpha


Enrollment: 20
Study Start Date: April 2009
Study Completion Date: July 2011
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Oliver Kimberger M.D.
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Braun Stiftung
Investigators
Principal Investigator: Oliver Kimberger, M.D. Medical University of Vienna
  More Information

Responsible Party: Oliver Kimberger, Assoc.Prof.PD Dr. MSc, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00876954     History of Changes
Other Study ID Numbers: PreopHypertherm1 
Study First Received: April 6, 2009
Last Updated: January 20, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: on request

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

ClinicalTrials.gov processed this record on September 23, 2016