Trial · NCT02428062
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-operative cognitive dysfunction (POCD) at 3 months | 3 months after surgical operation | For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group). The Z-score is calculated as the difference between the baseline and the 3 months test result for a patient, corrected for the expected difference (the mean difference for that test observed in the Control Group), divided by the standard deviation of the mean difference for that test observed in the Control Group. From the Z-scores of the single tests a combined Z-score can be calculated. Patients in whom the difference (worsening) in the score at 3 months to the score at baseline in at least 2 tests will be greater than 2 standard deviations from the expected difference (i.e. Z-score ≥ 2 in at least 2 tests), will be diagnosed with POCD. Also patients in which the combined Z-score will be equal or greater than 2 will be diagnosed with POCD. |
| Secondary | Post-operative cognitive dysfunction (POCD) at 1 year | 1 year after surgical operation | For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group). The Z-score is calculated as the difference between the baseline and the 1 year test result for a patient, corrected for the expected difference (the mean difference for that test observed in the Control Group), divided by the standard deviation of the mean difference for that test observed in the Control Group. From the Z-scores of the single tests a combined Z-score can be calculated. Patients in whom the difference (worsening) in the score at 1 year to the score at baseline in at least 2 tests will be greater than 2 standard deviations from the expected difference (i.e. Z-score ≥ 2 in at least 2 tests), will be diagnosed with POCD. Also patients in which the combined Z-score will be equal or greater than 2 will be diagnosed with POCD. |
| Secondary | Post-operative delirium | Within 7 days after surgical operation | During the first postoperative week all patients will be evaluated on a daily basis for delirium occurrence by the CAM-ICU scale (Confusion Assessment Method for the ICU). The CAM-ICU scale defines delirium by the simultaneous occurrence of items 1, 2 and one between items 3 and 4. Items are listed below: 1. Acute alteration of mental status or fluctuating mental status in the preceding 24 hours 2. Inattention 3. Altered level of consciousness (Richmond Agitation and Sedation Scale, RASS ≠ 0) 4. Disorganized thinking |
| Secondary | Hearing loss at 3 months | 3 months after surgical operation | Clinical evaluation of worsening in hearing function |
| Secondary | Hospital length of stay | Up to 30 days after surgical operation | Number of days of hospitalization after the surgical operation |
| Secondary | Mortality | 90 days | |
| Secondary | Number of patients with at least one post-operative complication | Within 7 days after surgical operation | During the first postoperative week patients will be assessed on a daily basis for the occurrence of cardio-pulmonary (acute myocardial infarction, congestive heart failure, pulmonary embolism, cardiac arrest, atrial fibrillation, pneumonia), neurologic (ischemic or hemorrhagic stroke), renal or hemorrhagic complications. |
| Secondary | Hearing loss at 1 year | 1 year after surgical operation | Clinical evaluation of worsening in hearing function |
| Secondary | Vestibular dysfunction at 3 months | 3 months after surgical operation | Clinical evaluation of worsening of vestibular function |
| Secondary | Vestibular dysfunction at 1 year | 1 year after surgical operation | Clinical evaluation of worsening of vestibular function |
| Other | Per protocol analysis of outcomes | Up to 30 days after surgical operation, at 3 months and 1 year | The incidence of the primary and secondary outcomes will be assessed in the Standard of Care arm vs the patients in the Treatment arm who spent at least 75% of the anesthesia time within the hemodynamic target (within 10% of baseline mean arterial blood pressure) |
| Other | Intraoperative hypotensive times | Up to 30 days after surgical operation, at 3 months and 1 year | The incidence of the primary and secondary outcomes will be assessed in relation to the absolute and relative time spent in any category of blood pressure defined as "hypotension" (either mild, moderate or severe) and to the absolute and relative time spent in each category of hypotension (mild, moderate or severe). This analysis will be performed on the entire patients population, irrespective of allocation arm. |
| Other | Intraoperative cerebral desaturations | Up to 30 days after surgical operation, at 3 months and 1 year | The incidence of the primary and secondary outcomes will be assessed in relation to the absolute and relative time spent with cerebral desaturation (non-invasive cerebral saturimetry \< 50%) and to the magnitude of cerebral desaturation episodes. This analysis will be performed on the entire patients population, irrespective of allocation arm. |
| Other | Subgroup analyses | Up to 30 days after surgical operation, at 3 months and 1 year | The incidence of the primary and secondary outcomes will be assessed in the following subgroup of patients: age stratification categories (age 75-79; 80-84; ≥ 85) surgery stratification categories (minor vs major surgery) education level (\<8 years; 8-13 years; \> 13 years education) normotensive vs hypertensive patients non-frail patients vs cognitive frail patients |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02428062/registered