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

NCT02364219 | Unknown

• 1 other identifier: EA1/348/14
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia

Keywords

prewarming; perioperative hypothermia; microdialysis; tissue oxygen saturation; cytoreductive surgery

Outcome Measures

Primary Outcomes (1)

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

  approximately 30-40 minutes

Secondary Outcomes (1)

• body core temperature at the end of surgery

  duration of surgery

Other Outcomes (2)

• prolonged need for ventilatory support

  10 days postoperative

• Changes in Microcirculation

  duration of surgery

Study Arms (4)

Standard

NO INTERVENTION

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

Standard + Microdialysis

EXPERIMENTAL

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

Prewarm

EXPERIMENTAL

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

Prewarm + Microdialysis

EXPERIMENTAL

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; Device: Microdialysis

Interventions

Prewarming OTHER

Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.

Prewarm; Prewarm + Microdialysis

Microdialysis DEVICE

71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden

Prewarm + Microdialysis; Standard + Microdialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch: collaborator

Study Sites (1)

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

Berlin, State of Berlin, 13353, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 31438849 DERIVED

MeSH Terms

Conditions

Hypothermia

Interventions

Microdialysis

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dialysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Michael Sander

  Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Sander

CONTACT

030450531-012; michael.sander@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. M. Sander

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 18, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

DE (1)