Surgical Site InfectionNCT03112317
Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery
An observational study of Surgical Site Infection and Bleeding, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
This study investigate associations between mild hypothermia (patients' core temperature ≤ 36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in patients undergoing major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Bleeding
- What is being tested?
- Prevention of hypothermia
- Type of treatment
- Injection or infusion
- How many people
- 3,059 participants
- Where
- 2 sitesNorway
- Study dates
- 30 May 2019to 31 Dec 2019
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consist of patients undergoing abdominal or gynecologic laparatomy or laparoscopy in a tertiary teaching hospital in Norway.
Who may be able to join
- Patients (men or women) above 18 years, undergoing abdominal or gynecological surgery with laparotomy or laparoscopy.
Who cannot join
- Surgical procedures with intentional reduction of core temperature. Patients under the age of 18.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, Hordaland, 5021
Haukeland University Hospital
Bergen, 5021
About this study
Official title: Does Mild Hypothermia Increase Intra-Operative Blood Loss and Surgical Site Infections in Major Abdominal Surgery?
This study investigate associations between mild hypothermia (patients' core temperature ≤ 36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in patients undergoing major abdominal surgery.
Read the detailed description
This study evaluates associations between patients' core temperature during surgery and intra-operative blood loss, and to SSI. Additionally, the investigators observe the use of hypothermia prevention measures in operating theaters, use of surgical safety checklists. SSI is registered at discharge from hospital and up to 30 days post-discharge.
The goal of the study is to contribute to focus on prevention of even mild hypothermia in surgery.
This study is of interest for healthcare personnel as operating room nurses, surgeons, nurse anaesthetists, anaesthesiologists, ward nurses, post anaesthetic care unit nurses, and other healthcare staff involved in the in-hospital surgical pathway.
- Conditions
- Surgical Site Infection, Bleeding
- Being tested
- Prevention of hypothermia
- Keywords
- Surgery, Hypothermia, Prevention, Surgical Site Infection, Bleeding, Surgical instruments
- Medical subject headings
- Surgical Wound Infection, Hemorrhage, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention of hypothermiaOther
Also called Forced air warming blankets
Patients are routinely warmed with forced air warming blankets, regular blankets, pre warmed intravenous fluid. Routines are ensured with use of the WHO Surgical Safety Checklist. The intervention is the use of operating theatre care measures to prevent mild hypothermia in surgical patients.
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Patients with mild hypothermia at start of the surgery Receives: Other: Prevention of hypothermia | |
| Normothermia | Patients with normal core temperature at start of surgery. Receives: Other: Prevention of hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative blood loss (mL) in surgical patients
Bleeding that occur during the surgical procedure
Measured: Within the surgical procedure
Secondary outcomes (5)
Peri-operative blood loss (registered by ICD-10 codes)
Bleeding requiring blood transfusion peri-operatively
Measured: Within the duration of the surgical procedures, an average of 2.5 hours
Number of patients with Surgical Site Infections after surgery
Post-operative surgical site infections present before discharge from hospital
Measured: Up to 30 days after discharge from hospital
Number of patients with Surgical Site Infection
Post-operative surgical site infection present after discharge from hospital
Measured: Up to 30 days after discharge from hospital
Days admitted in hospital
Length of stay in hospital
Measured: Hospital stay up to 13 days on average
Hours admitted in post operative care unit (PACU)
Length of stay in PACU
Measured: On average up to 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start30 May 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College of Southeast Norway
- Responsible party
- Sponsor
- Investigators
- Arvid S Haugen, PhD, MSc, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112317
- Sponsor's protocol ID
- REK Vest (2016/2193)
- Status last verified
- Feb 2020
- First submitted
- 26 Mar 2017
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous individual data is allowed to share, thought such request must be approved by the REK West. Data will be available from the primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mild Hypothermia Increase Intra-Operative Blood Loss and Surgical Site Infections in Major Abdominal Surgery?
- ClinicalTrials.gov ID
- NCT03112317
- Acronym / sponsor ID
- REK Vest (2016/2193)
- Conditions
- Surgical Site Infection, Bleeding
- Keywords
- Surgery, Hypothermia, Prevention, Surgical Site Infection, Bleeding, Surgical instruments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,059 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University College of Southeast Norway
- Study start
- 30 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
This study investigate associations between mild hypothermia (patients' core temperature ≤ 36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in patients undergoing major abdominal surgery.
Detailed description
This study evaluates associations between patients' core temperature during surgery and intra-operative blood loss, and to SSI. Additionally, the investigators observe the use of hypothermia prevention measures in operating theaters, use of surgical safety checklists. SSI is registered at discharge from hospital and up to 30 days post-discharge.
The goal of the study is to contribute to focus on prevention of even mild hypothermia in surgery.
This study is of interest for healthcare personnel as operating room nurses, surgeons, nurse anaesthetists, anaesthesiologists, ward nurses, post anaesthetic care unit nurses, and other healthcare staff involved in the in-hospital surgical pathway.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | – | Other: Prevention of hypothermiaPatients with mild hypothermia at start of the surgery |
| Normothermia | – | Other: Prevention of hypothermiaPatients with normal core temperature at start of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consist of patients undergoing abdominal or gynecologic laparatomy or laparoscopy in a tertiary teaching hospital in Norway.
Key inclusion criteria (1 listed)
- Patients (men or women) above 18 years, undergoing abdominal or gynecological surgery with laparotomy or laparoscopy.
Key exclusion criteria (1 listed)
- Surgical procedures with intentional reduction of core temperature. Patients under the age of 18.
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 |
|---|---|---|
| Prevention of hypothermiaAlso: Forced air warming blanketsPatients are routinely warmed with forced air warming blankets, regular blankets, pre warmed intravenous fluid. Routines are ensured with use of the WHO Surgical Safety Checklist. The intervention is the use of operating theatre care measures to prevent mild hypothermia in surgical patients. | Other | Hypothermia, Normothermia |
Primary outcome
Intra-operative blood loss (mL) in surgical patients
Time frame: Within the surgical procedure
Bleeding that occur during the surgical procedure
5 secondary outcomes
Peri-operative blood loss (registered by ICD-10 codes)
Time frame: Within the duration of the surgical procedures, an average of 2.5 hours
Number of patients with Surgical Site Infections after surgery
Time frame: Up to 30 days after discharge from hospital
Number of patients with Surgical Site Infection
Time frame: Up to 30 days after discharge from hospital
Days admitted in hospital
Time frame: Hospital stay up to 13 days on average
Hours admitted in post operative care unit (PACU)
Time frame: On average up to 14 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Yes. Anonymous individual data is allowed to share, thought such request must be approved by the REK West. Data will be available from the primary investigator.
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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.
Arvid S Haugen, PhD, MSc principal investigator
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection and Bleeding, run by Haukeland University Hospital at 2 sites in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative blood loss (mL) in surgical patients (time frame: Within the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2020.