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

Primary Purpose

Hypothermia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Prewarming
Microdialysis
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring prewarming, perioperative hypothermia, microdialysis, tissue oxygen saturation, cytoreductive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-KlinikumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Standard

Standard + Microdialysis

Prewarm

Prewarm + Microdialysis

Arm Description

Study arm in which patients are treated according to standard operating procedures. Acting as "control arm".

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.

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.

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

Outcomes

Primary Outcome Measures

body core temperature drop from induction of anesthesia to start of surgery

Secondary Outcome Measures

body core temperature at the end of surgery

Full Information

First Posted
January 20, 2015
Last Updated
February 19, 2015
Sponsor
Charite University, Berlin, Germany
Collaborators
Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch
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1. Study Identification

Unique Protocol Identification Number
NCT02364219
Brief Title
Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial
Acronym
PREWARM
Official Title
Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial (PREWARM)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
prewarming, perioperative hypothermia, microdialysis, tissue oxygen saturation, cytoreductive surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm Description
Study arm in which patients are treated according to standard operating procedures. Acting as "control arm".
Arm Title
Standard + Microdialysis
Arm Type
Experimental
Arm Description
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.
Arm Title
Prewarm
Arm Type
Experimental
Arm Description
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.
Arm Title
Prewarm + Microdialysis
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Prewarming
Intervention Description
Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
Intervention Type
Device
Intervention Name(s)
Microdialysis
Intervention Description
71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden
Primary Outcome Measure Information:
Title
body core temperature drop from induction of anesthesia to start of surgery
Time Frame
approximately 30-40 minutes
Secondary Outcome Measure Information:
Title
body core temperature at the end of surgery
Time Frame
duration of surgery
Other Pre-specified Outcome Measures:
Title
prolonged need for ventilatory support
Description
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)
Time Frame
10 days postoperative
Title
Changes in Microcirculation
Description
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
Time Frame
duration of surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Sander
Phone
030450531-012
Ext
-052
Email
michael.sander@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Sander
Organizational Affiliation
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sander
First Name & Middle Initial & Last Name & Degree
Lutz Kaufner
First Name & Middle Initial & Last Name & Degree
Phil Niggemann
First Name & Middle Initial & Last Name & Degree
Roland Francis
First Name & Middle Initial & Last Name & Degree
Mezger Viktor

12. IPD Sharing Statement

Citations:
PubMed Identifier
31438849
Citation
Kaufner L, Niggemann P, Baum T, Casu S, Sehouli J, Bietenbeck A, Boschmann M, Spies CD, Henkelmann A, von Heymann C. Impact of brief prewarming on anesthesia-related core-temperature drop, hemodynamics, microperfusion and postoperative ventilation in cytoreductive surgery of ovarian cancer: a randomized trial. BMC Anesthesiol. 2019 Aug 22;19(1):161. doi: 10.1186/s12871-019-0828-1.
Results Reference
derived

Learn more about this trial

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

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