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Completed

NCT Number: NCT00876954

Preoperative Hyperthermia in Major Abdominal Surgery Patients

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oliver Kimberger M.D.

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Normothermia

Procedure

Warming without increase in core temperature

Hyperthermia

Procedure

Core hyperthermia (39 °C) for 2,5 hours

Primary outcomes

  1. Immune Status

    Time frame: 24 hours after surgery

    LPS induced TNF-alpha

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Braun Stiftung

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 7, 2009
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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