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Preoperative Hyperthermia in Major Abdominal Surgery Patients

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Normothermia
Hyperthermia
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oliver Kimberger M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Hyperthermia

Arm Description

Warming without increase in core temperature

Hyperthermia for 2,5 hours (39 °C core temperature)

Outcomes

Primary Outcome Measures

Immune Status
LPS induced TNF-alpha

Secondary Outcome Measures

Full Information

First Posted
April 6, 2009
Last Updated
January 20, 2016
Sponsor
Medical University of Vienna
Collaborators
Braun Stiftung
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1. Study Identification

Unique Protocol Identification Number
NCT00876954
Brief Title
Preoperative Hyperthermia in Major Abdominal Surgery Patients
Official Title
Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Braun Stiftung

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Warming without increase in core temperature
Arm Title
Hyperthermia
Arm Type
Active Comparator
Arm Description
Hyperthermia for 2,5 hours (39 °C core temperature)
Intervention Type
Procedure
Intervention Name(s)
Normothermia
Intervention Description
Warming without increase in core temperature
Intervention Type
Procedure
Intervention Name(s)
Hyperthermia
Intervention Description
Core hyperthermia (39 °C) for 2,5 hours
Primary Outcome Measure Information:
Title
Immune Status
Description
LPS induced TNF-alpha
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Kimberger, M.D.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oliver Kimberger M.D.
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
on request

Learn more about this trial

Preoperative Hyperthermia in Major Abdominal Surgery Patients

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