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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hypothermia

Intervention / Treatment
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* Other: Prewarming
* Device: Microdialysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Study arm in which patients are treated according to standard operating procedures. Acting as control arm. | |
| Experimental: Standard + Microdialysis<br>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<br>* 71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden<br>|
| Experimental: Prewarm<br>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<br>* Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.<br>|
| Experimental: Prewarm + Microdialysis<br>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 | Other: Prewarming<br>* Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.<br>Device: Microdialysis<br>* 71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body core temperature at the end of surgery |  | duration of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prewarming, perioperative hypothermia, microdialysis, tissue oxygen saturation, cytoreductive surgery