HypothermiaPREWARMNCT02364219
Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial
A study testing Prewarming and Microdialysis in people with Hypothermia, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypothermia
- What is being tested?
- Prewarming and Microdialysis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18
- elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, State of Berlin, 13353
Michael Sander
Lutz Kaufner
About this study
Official title: Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial (PREWARM)
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
- Being tested
- Prewarming, Microdialysis
- Keywords
- prewarming, perioperative hypothermia, microdialysis, tissue oxygen saturation, cytoreductive surgery
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrewarmingOther
Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
MicrodialysisDevice
71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Prewarming; Device: Microdialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
body core temperature drop from induction of anesthesia to start of surgery
Measured: approximately 30-40 minutes
Secondary outcomes (1)
body core temperature at the end of surgery
Measured: duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch
- Responsible party
- Principal investigator, Michael Sander, Charite University, Berlin, Germany
- Investigators
- Michael Sander, Principal investigator, Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364219
- Sponsor's protocol ID
- EA1/348/14
- Acronym
- PREWARM
- Status last verified
- Feb 2015
- First submitted
- 20 Jan 2015
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31438849
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial (PREWARM)
- ClinicalTrials.gov ID
- NCT02364219
- Acronym / sponsor ID
- PREWARM / EA1/348/14
- Conditions
- Hypothermia
- Keywords
- prewarming, perioperative hypothermia, microdialysis, tissue oxygen saturation, cytoreductive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Dr. Michael Boschmann, Experimental & Clinical Research Center(ECRC), Charité Berlin-Buch
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Study arm in which patients are treated according to standard operating procedures. Acting as "control arm". |
| Standard + Microdialysis | Experimental | Device: MicrodialysisStudy 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. |
| Prewarm | Experimental | Other: PrewarmingStudy 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. |
| Prewarm + Microdialysis | Experimental | Other: Prewarming, Device: MicrodialysisStudy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18
- elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary
Key exclusion criteria (13 listed)
- age < 18
- refusal participate in study
- pregnant or breast-feeding women
- cardiac ejection fraction < 30%
- terminal renal insufficiency requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrewarmingPatients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia. | Other | Prewarm, Prewarm + Microdialysis |
| Microdialysis71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden | Device | Prewarm + Microdialysis, Standard + Microdialysis |
Primary outcome
body core temperature drop from induction of anesthesia to start of surgery
Time frame: approximately 30-40 minutes
1 secondary outcome
body core temperature at the end of surgery
Time frame: duration of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Derived from this study: PubMed 31438849Kaufner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sander principal investigator
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prewarming and Microdialysis in people with Hypothermia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Sander (030450531-012 ext. -052, michael.sander@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body core temperature drop from induction of anesthesia to start of surgery (time frame: approximately 30-40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.