Trial · NCT02726620
Decision Support for Intraoperative Low Blood Pressure
NCT02726620, Not applicable, Completed, Vanderbilt University Medical Center; results first posted 2019-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Decision Support for Intraoperative Low Blood Pressure. Trials, record NCT02726620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02726620
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Decision Support for Intraoperative Low Blood Pressure
- NCT number
- NCT02726620
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 22,435 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Hypotension
- Interventions
Attending real-time decision support, In-room real-time decision support, Attending feedback emails, In-room provider feedback emails, Anesthesia Information Management System (AIMS), Perioperative Data Warehouse (PDW), General anesthesia, Pager system, Central neuraxial anesthesia, Non-cardiac surgery, Propofol, Sevoflurane, Desflurane, Isoflurane, Ephedrine, Phenylephrine, Norepinephrine, Epinephrine, Dobutamine, Dopamine, Isoproterenol, Milrinone, Atropine, Glycopyrrolate, Vasopressin, Terlipressin, Sodium Chloride 0.9%, Ringer's lactate, Hydroxyethyl starch solutions, Fresh Frozen Plasma, Packed Red Blood Cells, Albumin solutions, Plasma-Lyte, Lidocaine, Bupivacaine, Levobupivacaine, Ropivacaine, Mepivacaine, Tetracaine, Prilocaine, Procaine, Chloroprocaine, Benzocaine, Articaine
- First posted
- 2016-04-04
- Last updated
- 2019-05-16
- Results first posted
- 2019-05-16
- Limitations and caveats
1. Due to development issues the UMC Utrecht could not participate: myocardial injury was dropped as primary outcome, as well as some secondary outcomes.~2. Technical issues at the VUMC resulted in absent IOH notifications (see 'Participant Flow').
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postoperative Acute Kidney Injury | Within 7 days after surgery | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 30-day Mortality | 30 days after surgery | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). For a large group of patients no mortality information was available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | In-hospital Mortality | All postoperative days during a single hospital admission, expected median of 5 days | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Postoperative Acute Kidney Injury Stage 2 | Within 7 days after surgery | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Postoperative Rise in Creatinine Levels | Within 7 days after surgery | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). Patients with no routine postoperative creatinine measurements are excluded from the analysis. | mg/dL | MEDIAN |
| SECONDARY | Incidence of a MAP < 60 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of a MAP < 55 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of a MAP < 50 mmHg | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postoperative Acute Kidney Injury | Usual Care Group | AKI stage I or greater | 1333 | Participants | |
| Postoperative Acute Kidney Injury | Hypotension Decision Support | AKI stage I or greater | 372 | Participants | |
| Postoperative Acute Kidney Injury | Usual Care Group | No AKI - Confirmed by measurement | 9670 | Participants | |
| Postoperative Acute Kidney Injury | Hypotension Decision Support | No AKI - Confirmed by measurement | 2785 | Participants | |
| Postoperative Acute Kidney Injury | Usual Care Group | No postoperative creatinine measurement | 4621 | Participants | |
| Postoperative Acute Kidney Injury | Hypotension Decision Support | No postoperative creatinine measurement | 1171 | Participants | |
| 30-day Mortality | Usual Care Group | 511 | Participants | ||
| 30-day Mortality | Hypotension Decision Support | 143 | Participants | ||
| In-hospital Mortality | Usual Care Group | 487 | Participants | ||
| In-hospital Mortality | Hypotension Decision Support | 137 | Participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow38
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Historic Cohort - Three Years | STARTED | Usual Care Group | 17,463 | |
| Historic Cohort - Three Years | STARTED | Hypotension Decision Support | 0 | |
| Historic Cohort - Three Years | MAP < 65 mmHg: Primary Analysis | Usual Care Group | 15,624 | |
| Historic Cohort - Three Years | MAP < 65 mmHg: Primary Analysis | Hypotension Decision Support | 0 | |
| Historic Cohort - Three Years | COMPLETED | Usual Care Group | 17,463 | |
| Historic Cohort - Three Years | COMPLETED | Hypotension Decision Support | 0 | |
| Historic Cohort - Three Years | NOT COMPLETED | Usual Care Group | 0 | |
| Historic Cohort - Three Years | NOT COMPLETED | Hypotension Decision Support | 0 | |
| Month 1: Attending Randomization | STARTED | Usual Care Group | 0 | |
| Month 1: Attending Randomization | STARTED | Hypotension Decision Support | 485 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 participant flowAdverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Acute Kidney Injury Stage I or greater | Renal and urinary disorders | Usual Care Group | 1,477 | 17,463 | |
| serious | Acute Kidney Injury Stage I or greater | Renal and urinary disorders | Hypotension Decision Support | 435 | 4,972 | |
| serious | Mortality | Investigations | Usual Care Group | 534 | 17,463 | |
| serious | Mortality | Investigations | Hypotension Decision Support | 158 | 4,972 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care Group | 534 | 17,463 |
| Total, all-cause mortality | Hypotension Decision Support | 158 | 4,972 |
| Total, other adverse events | Usual Care Group | 0 | 17,463 |
| Total, other adverse events | Hypotension Decision Support | 0 | 4,972 |
| Total, serious adverse events | Usual Care Group | 1,811 | 17,463 |
| Total, serious adverse events | Hypotension Decision Support | 541 | 4,972 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons18
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hypotension Decision Support vs Usual Care Group: Incidence of a MAP < 50 mmHg for > 20 Minutes | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: Usage Frequency of Cardiovascular Drugs: Glycopyrrolate | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: Usage Frequency of Cardiovascular Drugs: Ephinephrine | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: Incidence of a MAP < 60 mmHg | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: Incidence of a MAP < 50 mmHg for > 10 Minutes | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: Usage Frequency of Cardiovascular Drugs: Phenylephrine | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: In-hospital Mortality | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: 30-day Mortality | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: Incidence of a MAP < 55 mmHg | Trial comparisons |
| Hypotension Decision Support vs Usual Care Group: Usage Frequency of Cardiovascular Drugs: Ephedrine | Trial comparisons |
1 to 10 of 18
See all 18 trial comparisonsTests0
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/NCT02726620
GET https://conductscience.org/api/trials/v1/NCT02726620/registered?page=2