Preoperative Hyperthermia in Major Abdominal Surgery Patients
Phase 1
Completed
- Conditions
- Colon Cancer
- Interventions
- Procedure: NormothermiaProcedure: Hyperthermia
- Registration Number
- NCT00876954
- Lead Sponsor
- Medical University of Vienna
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Normothermia Warming without increase in core temperature Hyperthermia Hyperthermia Hyperthermia for 2,5 hours (39 °C core temperature)
- Primary Outcome Measures
Name Time Method Immune Status 24 hours after surgery LPS induced TNF-alpha
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oliver Kimberger M.D.
🇦🇹Vienna, Austria