Clinical trial NCT02364219: Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial
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
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia
Keywords: prewarming
perioperative hypothermia
microdialysis
tissue oxygen saturation
cytoreductive surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch
First posted: 2015-02-18
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: body core temperature drop from induction of anesthesia to start of surgery
timeFrame: approximately 30-40 minutes
Secondary outcomes:
measure: body core temperature at the end of surgery
timeFrame: duration of surgery
Other outcomes:
measure: prolonged need for ventilatory support
timeFrame: 10 days postoperative
measure: Changes in Microcirculation
timeFrame: duration of surgery
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Berlin
name: Michael Sander
role: PRINCIPAL_INVESTIGATOR
References:
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.