Preoperative Hyperthermia in Major Abdominal Surgery Pati... | NCT00876954

Studies
Preoperative Hyperthermia in Major Abdominal Surgery Patients

NCT00876954

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jan 21, 2016Estimated

Enrollment

20Actual

Phase

Phase 1Phase 2

Conditions

Colon Cancer

Interventions

Normothermia
Hyperthermia

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Jul 2011Actual

First Submitted Date

Apr 6, 2009

First Submission Date that Met QC Criteria

Apr 6, 2009

First Posted Date

Apr 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Name	Class
Braun Stiftung	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Normothermia	Procedure	Warming without increase in core temperature	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune Status	LPS induced TNF-alpha	24 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Kimberger, M.D.	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oliver Kimberger M.D.		Vienna	State of Vienna	1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

on request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003972	Diathermy

Ancestor Terms

ID	Term
D006979	Hyperthermia, Induced
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided