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NCT00876954 Clinical Trial

Preoperative Hyperthermia in Major Abdominal Surgery Patients

Colon Cancer Clinical Trial

Official title:
Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00876954
Other study ID # PreopHypertherm1
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 6, 2009
Last updated January 20, 2016
Start date April 2009
Est. completion date July 2011

Study information
Verified date January 2016
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date July 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Normothermia
Warming without increase in core temperature
• Hyperthermia
Core hyperthermia (39 °C) for 2,5 hours

Locations
Country Name City State
Austria Oliver Kimberger M.D. Vienna

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Vienna Braun Stiftung

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune Status LPS induced TNF-alpha 24 hours after surgery No
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