NCT00876954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

April 6, 2009

Last Update Submit

January 20, 2016

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Immune Status

    LPS induced TNF-alpha

    24 hours after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Warming without increase in core temperature

Procedure: Normothermia

Hyperthermia

ACTIVE COMPARATOR

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

Procedure: Hyperthermia

Interventions

NormothermiaPROCEDURE

Warming without increase in core temperature

Placebo
HyperthermiaPROCEDURE

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

Hyperthermia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients, age 18 - 75
  • Open abdominal, curative cancer surgery \> 2 h

You may not qualify if:

  • Pregnancy
  • Chronic cortisone treatment
  • Ongoing chemotherapy
  • Acute infections, septic surgery
  • Palliative surgery (e.g. debulking only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oliver Kimberger M.D.

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Oliver Kimberger, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.PD Dr. MSc

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2010

Study Completion

July 1, 2011

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

AU(1)