Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial (PREWARM)

February 19, 2015 updated by: Michael Sander, Charite University, Berlin, Germany

Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial (PREWARM)

The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
        • Principal Investigator:
          • Michael Sander
        • Sub-Investigator:
          • Lutz Kaufner
        • Sub-Investigator:
          • Phil Niggemann
        • Sub-Investigator:
          • Mezger Viktor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age > 18
  • elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary

Exclusion Criteria:

  • age < 18
  • refusal participate in study
  • pregnant or breast-feeding women
  • cardiac ejection fraction < 30%
  • terminal renal insufficiency requiring dialysis
  • severe pulmonary disease (Gina-Classification< 3)
  • neurological and/or psychiatric disease
  • patient is placed in an institution due to court order
  • lack of language skills/understanding
  • employee of Charité Berlin
  • alcohol addiction
  • refusal of epidural anesthesia or failure to insert epidural catheter
  • participation in other perioperative, invasive studies which prohibit further study inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard
Study arm in which patients are treated according to standard operating procedures. Acting as "control arm".
Experimental: Standard + Microdialysis
Study arm in which patients are treated according to standard operating procedures but also receive Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue.
Device: Microdialysis
71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden
Experimental: Prewarm
Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
Other: Prewarming
Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
Experimental: Prewarm + Microdialysis
Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia and Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue
Device: Microdialysis
71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden
Other: Prewarming
Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body core temperature drop from induction of anesthesia to start of surgery
Time Frame: approximately 30-40 minutes
approximately 30-40 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
body core temperature at the end of surgery
Time Frame: duration of surgery
duration of surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
prolonged need for ventilatory support
Time Frame: 10 days postoperative
Goal is to determine whether discrepancies between the different groups regarding prolonged postoperative need for ventilatory support.Defined through length of ventilation after surgery (hours)
10 days postoperative
Changes in Microcirculation
Time Frame: duration of surgery
Goal is to determine whether the prewarming and hypothetically improved perioperative warming results in increased microcirculation determined through microdialysis.Measured in lactate/pyruvate (µmol/L) ratio
duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch

Investigators

  • Principal Investigator: Michael Sander, Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

February 16, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/348/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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