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

Hypothermia Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02364219
• Other study ID #: EA1/348/14
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2015
• Last updated: February 19, 2015
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: Michael Sander
• Phone: 030450531-012
• Email: michael.sander[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia

Intervention

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.

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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	prolonged need for ventilatory support	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	No
Other	Changes in Microcirculation	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	No
Primary	body core temperature drop from induction of anesthesia to start of surgery		approximately 30-40 minutes	No
Secondary	body core temperature at the end of surgery		duration of surgery	No