Preoperative Hyperthermia in Major Abdominal Surgery Patients

NCT ID: NCT00876954

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Warming without increase in core temperature

Group Type PLACEBO_COMPARATOR

Normothermia

Intervention Type PROCEDURE

Warming without increase in core temperature

Hyperthermia

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

Group Type ACTIVE_COMPARATOR

Hyperthermia

Intervention Type PROCEDURE

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

Interventions

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Normothermia

Warming without increase in core temperature

Intervention Type PROCEDURE

Hyperthermia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Braun Stiftung

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Oliver Kimberger

Assoc.Prof.PD Dr. MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Kimberger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Oliver Kimberger M.D.

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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PreopHypertherm1

Identifier Type: -

Identifier Source: org_study_id

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