Trial · NCT06885268
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Perioperative hypotension | During and up to 4 hours after surgery | Number of episodes of perioperative hypotension defined as any mean arterial pressure (MAP) reading ≤55 mm Hg in the setting of a continuous blood pressure measurement. |
| Secondary | Myocardial Injury after Non-cardiac Surgery (MINS) | During hospitalization and up to 30 days after surgery | Number of patients who experience MINS defined as any myocardial infarction and any acutely elevated postoperative cardiac troponin judged as resulting from myocardial ischemia using Roche's fifth generation Elecsys hsTnT, with an established cut-off of 20 ng/L combined with an absolute change of 5 ng/L or more (judged as due to ischemia) |
| Secondary | Acute kidney injury fulfilling Kidney Disease Improving Global Outcomes (KDIGO) criteria | During hospitalization and up to 30 days after surgery | Number of patients who experience an acute kidney injury (fulfilling KDIGO criteria) |
| Secondary | Stroke | During hospitalization and up to 30 days after surgery | Number of patients who experience a stroke is defined as a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours or leading to death. Stroke will be sub-classified into hemorrhagic and non-hemorrhagic stroke. |
| Secondary | Non-fatal cardiac arrest | During hospitalization and up to 30 days after surgery | Number of patients who experience non-fatal cardiac arrest defined as successful resuscitation from either documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, or pulseless electrical activity (PEA) requiring cardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation |
| Secondary | Sepsis | During hospitalization and up to 30 days after surgery | Number of patients who experience sepsis is defined as an increase in SOFA score of 2 or more, with evidence of infection. This outcome includes septic shock defined as sepsis with shock (vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mM \[above18 mg/dL\] in the absence of hypovolemia). Infection is defined as a pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms. |
| Secondary | Death | During hospitalization and up to 30 days after surgery | Number of patients who die of any cause |
| Secondary | Infusion-related reactions | During the infusion of noradrenaline and up to 30 days after drug administration, with assessment occurring postoperatively. | The number of patients who experience infusion-related reactions, defined as disorders such as flushing, rash, fever, rigors, chills, dyspnoea, bronchospasms, cardiac dysfunction, and anaphylaxis. Grades of infusion site extravasation are defined according to the Common Terminology Criteria for Adverse Events. |
| Secondary | Days alive and out of hospital | 30 days after surgery | Number of days when a patient is alive and out of hospital |
| Secondary | Clinically important atrial fibrillation | During hospitalization and up to 30 days after surgery | Number of patients who experience clinically important atrial fibrillation, defined as new-onset atrial fibrillation or atrial flutter of any duration on an ECG or rhythm strip, which results in angina, congestive heart failure, symptomatic hypotension, or requires treatment with a rate-controlling drug, antiarrhythmic drug, or electrical cardioversion |
| Secondary | Major bleeding | During hospitalization and up to 30 days after surgery | Number of patients who experience an International Society on Thrombosis and Haemostasis (ISTH) major bleeding |
| Secondary | Peripheral ischemia | During hospitalization and up to 30 days after surgery | Number of patients who experience peripheral ischemia defined as the fingertip necrosis of upper and lower limbs |
| Other | Lowest MAP throughout the procedure | During surgery | Number of patients who experience the lowest MAP throughout the procedure, defined as the lowest punctual measurement of mean arterial pressure |
| Other | Median mean arterial pressure | During and up to 4 hours after surgery | |
| Other | Median heart rate | During and up to 4 hours after surgery | |
| Other | Acute Myocardial Infarction | During hospitalization and up to 30 days after surgery | Number of patients who experience acute myocardial injury according to the Fourth Universal Definition of Myocardial Infarction as a detection of an elevated cTn value above the 99th percentile URL with a rise and/or fall of cTn values. |
| Other | Peak troponin concentration | The first three days after surgery | Peak troponin concentration |
| Other | Area under the curve troponin | The first three days after surgery | Area under the curve troponin is defined as total cTn release measured as area under the Troponin-Time curve |
| Other | Bradycardia | During surgery, up to 4 hours after surgery, and up to 30 days after surgery. | Number of patients who experience bradycardia, defined as a heart rate less than 40 beats per minute |
| Other | Acute congestive heart failure | During hospitalization and up to 30 days after surgery | Number of patients who experience acute congestive heart failure defined as an episode characterized by at least one of the following clinical signs (i.e. any of the following signs: elevated jugular venous pressure, respiratory rales/crackles, crepitations, or presence of S3) and at least one of the following: (I) Radiographic findings (i.e. vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) OR (II) Heart failure treatment implemented with diuretics with documented clinical improvement |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT06885268/registered