Trial · NCT03111875
Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
NCT03111875, Not applicable, Completed, The Cleveland Clinic; results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery. Trials, record NCT03111875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03111875
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
- NCT number
- NCT03111875
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 5,056 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Perioperative Care, Surgery--Complications, Hypothermia; Anesthesia, Myocardial Injury
- Interventions
- aggressive warming, routine thermal management
- First posted
- 2017-04-13
- Last updated
- 2023-08-01
- Results first posted
- 2023-08-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality | From the end of surgery to 30 days after surgery | The primary outcome was a composite of myocardial injury after non-cardiac surgery, non-fatal cardiac arrest, and all-cause mortality within 30 days of surgery. Myocardial injury was diagnosed when available troponin concentrations exceeded generation-specific and type-specific thresholds and were apparently of ischaemic origin (ie, no other obvious cause for artifactual elevation). We used the following thresholds based on available literature at time of adjudication: 1) non-high-sensitivity (fourth-generation) troponin T ≥0.03 ng/ml2; 2) high-sensitivity troponin T ≥65 ng/L; or high-sensitivity troponin T 20-64 ng/L and an increase ≥5 ng/L from baseline3; 3) high-sensitivity troponin I (Abbott assay) is ≥75 ng/L4; 4) high-sensitivity troponin I (Siemens assay) is ≥60 ng/L5; or, 5) troponin I (other assays) greater than local 99th percentiles. Myocardial infarction diagnosis required both troponin elevation and at least one diagnostic symptom or sign. |
| Secondary | Deep or Organ-space Surgical Site Infection | From the end of surgery to 30 days after surgery | Surgical site infection is defined by US Centers for Disease Control and Prevention criteria. It is consisted of superficial infection, deep infection, and organ-space infection. Superficial infection: Infection involves only skin or subcutaneous tissue of the incision. Deep infection: Infection appears to be related to the operation and infection involves deep soft tissues (e.g., fascial and muscle layers) of the incision. Organ-space infection: Infection involves any part of the anatomy (e.g., organs or spaces), other than the incision, which was opened or manipulated during an operation. |
| Secondary | Number of Patients Requiring Intraoperative Transfusion | From surgery start to surgery end | intraoperative transfusion will be yes if this patient received more than 0 unit of red blood cells. |
| Secondary | Duration of Hospitalization | From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized | The length of hospital stay in days, censored at 30 days |
| Secondary | Readmission | From the end of surgery to 30 days after surgery | Readmission to a hospital within a month of surgery |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality | From the end of surgery to 30 days after surgery | 16 patients were missing in Routine thermal management and 10 patients were missing in aggressive thermal management group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Deep or Organ-space Surgical Site Infection | From the end of surgery to 30 days after surgery | 20 patients were missing on this outcome in aggressive thermal management group and 27 patients were missing in routine thermal management group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Requiring Intraoperative Transfusion | From surgery start to surgery end | 13 patients missing on this outcome from treatment group and 20 patients missing on this outcome from control group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Hospitalization | From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized | 35 patients were missing on this outcome from treatment group and 41 patients were missing on this outcome from control group | days | MEDIAN |
| SECONDARY | Readmission | From the end of surgery to 30 days after surgery | 59 patients were missing on this outcome from control group and 45 patients were missing on this outcome from treatment group | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality | Routine Thermal Management | 239 | Participants | ||
| Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality | Aggressive Thermal Management | 246 | Participants | ||
| Deep or Organ-space Surgical Site Infection | Routine Thermal Management | 157 | Participants | ||
| Deep or Organ-space Surgical Site Infection | Aggressive Thermal Management | 178 | Participants | ||
| Number of Patients Requiring Intraoperative Transfusion | Routine Thermal Management | 236 | Participants | ||
| Number of Patients Requiring Intraoperative Transfusion | Aggressive Thermal Management | 254 | Participants | ||
| Duration of Hospitalization | Routine Thermal Management | 8 | Inter-Quartile Range 6 to 12 | days | |
| Duration of Hospitalization | Aggressive Thermal Management | 8 | Inter-Quartile Range 6 to 12 | days | |
| Readmission | Routine Thermal Management | 135 | Participants | ||
| Readmission | Aggressive Thermal Management | 161 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Routine Thermal Management | 2,529 | |
| Overall Study | STARTED | Aggressive Thermal Management | 2,527 | |
| Overall Study | COMPLETED | Routine Thermal Management | 2,506 | |
| Overall Study | COMPLETED | Aggressive Thermal Management | 2,507 | |
| Overall Study | NOT COMPLETED | Routine Thermal Management | 23 | |
| Overall Study | NOT COMPLETED | Aggressive Thermal Management | 20 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cardiac disorders | Cardiac disorders | Routine Thermal Management | 5 | 2,506 | 5 |
| other | Cardiac disorders | Cardiac disorders | Aggressive Thermal Management | 5 | 2,507 | 5 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Routine Thermal Management | 2 | 2,506 | 2 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Aggressive Thermal Management | 0 | 2,507 | 0 |
| other | General disorders | General disorders | Routine Thermal Management | 1 | 2,506 | 1 |
| other | General disorders | General disorders | Aggressive Thermal Management | 3 | 2,507 | 3 |
| other | Infections and infestations | Infections and infestations | Routine Thermal Management | 1 | 2,506 | 1 |
| other | Infections and infestations | Infections and infestations | Aggressive Thermal Management | 2 | 2,507 | 2 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Routine Thermal Management | 10 | 2,506 | 10 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Aggressive Thermal Management | 8 | 2,507 | 8 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Routine Thermal Management | 24 | 2,506 |
| Total, all-cause mortality | Aggressive Thermal Management | 18 | 2,507 |
| Total, other adverse events | Routine Thermal Management | 24 | 2,506 |
| Total, other adverse events | Aggressive Thermal Management | 22 | 2,507 |
| Total, serious adverse events | Routine Thermal Management | 30 | 2,506 |
| Total, serious adverse events | Aggressive Thermal Management | 17 | 2,507 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Routine Thermal Management vs Aggressive Thermal Management: Readmission | Trial comparisons |
| Routine Thermal Management vs Aggressive Thermal Management: Deep or Organ-space Surgical Site Infection | Trial comparisons |
| Routine Thermal Management vs Aggressive Thermal Management: Number of Patients Requiring Intraoperative Transfusion | Trial comparisons |
| Routine Thermal Management vs Aggressive Thermal Management: deaths from any cause | Trial comparisons |
Routine Thermal Management vs Aggressive Thermal Management: Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality | Trial comparisons |
| Routine Thermal Management vs Aggressive Thermal Management: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03111875
GET https://conductscience.org/api/trials/v1/NCT03111875/events?page=2