Trial · NCT02726620
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative Acute Kidney Injury | Within 7 days after surgery | Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or \>0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to \> 4, or initiation of renal replacement therapy. |
| Secondary | 30-day Mortality | 30 days after surgery | Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days) |
| Secondary | In-hospital Mortality | All postoperative days during a single hospital admission, expected median of 5 days | Hospital mortality rate during a single hospital admission after the surgery |
| Secondary | Postoperative Acute Kidney Injury Stage 2 | Within 7 days after surgery | Postoperative Acute Kidney Injury (AKI), Stage II or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or \>0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to \> 4, or initiation of renal replacement therapy. |
| Secondary | Postoperative Rise in Creatinine Levels | Within 7 days after surgery | Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported. |
| Secondary | Incidence of a MAP < 60 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 60 mmHg during anesthesia for 1 minute or more. |
| Secondary | Incidence of a MAP < 55 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 55 mmHg during anesthesia for 1 minute or more. |
| Secondary | Incidence of a MAP < 50 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 50 mmHg during anesthesia for 1 minute or more. |
| Secondary | Incidence of a MAP < 60 mmHg for > 10 Minutes | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. |
| Secondary | Incidence of a MAP < 55 mmHg for > 10 Minutes | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. |
| Secondary | Incidence of a MAP < 50 mmHg for > 10 Minutes | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. |
| Secondary | Incidence of a MAP < 60 mmHg for > 20 Minutes | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. |
| Secondary | Incidence of a MAP < 55 mmHg for > 20 Minutes | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. |
| Secondary | Incidence of a MAP < 50 mmHg for > 20 Minutes | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Incidence of a mean arterial pressure (MAP) \< 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. |
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. |
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. |
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. |
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. |
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. |
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. |
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.
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