N/A
N=17,463
Decision Support for Intraoperative Low Blood Pressure
Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT02726620 ↗Enrolled (actual)
17,463
Serious AEs
10.5%
Results posted
May 2019
Primary outcome: Primary: Postoperative Acute Kidney Injury — 1333; 372; 9670; 2785 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Attending real-time decision support (Procedure); In-room real-time decision support (Procedure); Attending feedback emails (Procedure); In-room provider feedback emails (Procedure); Anesthesia Information Management System (AIMS) (Device); Perioperative Data Warehouse (PDW) (Device); General anesthesia (Procedure); Pager system (Device); Central neuraxial anesthesia (Procedure); Non-cardiac surgery (Procedure); Propofol (Drug); Sevoflurane (Drug); Desflurane (Drug); Isoflurane (Drug); Ephedrine (Drug); Phenylephrine (Drug); Norepinephrine (Drug); Epinephrine (Drug); Dobutamine (Drug); Dopamine (Drug); Isoproterenol (Drug); Milrinone (Drug); Atropine (Drug); Glycopyrrolate (Drug); Vasopressin (Drug); Terlipressin (Drug); Sodium Chloride 0.9% (Drug); Ringer's lactate (Drug); Hydroxyethyl starch solutions (Drug); Fresh Frozen Plasma (Drug); Packed Red Blood Cells (Drug); Albumin solutions (Drug); Plasma-Lyte (Drug); Lidocaine (Drug); Bupivacaine (Drug); Levobupivacaine (Drug); Ropivacaine (Drug); Mepivacaine (Drug); Tetracaine (Drug); Prilocaine (Drug); Procaine (Drug); Chloroprocaine (Drug); Benzocaine (Drug); Articaine (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Acute Kidney Injury |
1477; 435; 10690; 3166; 5296; 1371 | — |
| SECONDARY 30-day Mortality |
511; 143 | — |
| SECONDARY In-hospital Mortality |
487; 137 | — |
| SECONDARY Postoperative Acute Kidney Injury Stage 2 |
1; 0; 11002; 3157; 4621; 1171 | — |
| SECONDARY Postoperative Rise in Creatinine Levels |
0.00; 0.00 | — |
| SECONDARY Incidence of a MAP < 60 mmHg |
13779; 3798 | — |
| SECONDARY Incidence of a MAP < 55 mmHg |
10991; 3045 | — |
| SECONDARY Incidence of a MAP < 50 mmHg |
7781; 2196 | — |
| SECONDARY Incidence of a MAP < 60 mmHg for > 10 Minutes |
6989; 1723 | — |
| SECONDARY Incidence of a MAP < 55 mmHg for > 10 Minutes |
3181; 759 | — |
| SECONDARY Incidence of a MAP < 50 mmHg for > 10 Minutes |
1159; 326 | — |
| SECONDARY Incidence of a MAP < 60 mmHg for > 20 Minutes |
3632; 792 | — |
| SECONDARY Incidence of a MAP < 55 mmHg for > 20 Minutes |
1223; 284 | — |
| SECONDARY Incidence of a MAP < 50 mmHg for > 20 Minutes |
304; 85 | — |
| SECONDARY Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg |
485; 417 | — |
| SECONDARY Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg |
273; 235 | — |
| SECONDARY Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg |
96; 86 | — |
| SECONDARY Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg |
57; 52 | — |
| SECONDARY Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg |
23; 23 | — |
| SECONDARY Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg |
19; 19 | — |
| SECONDARY Estimated Intraoperative Blood Loss |
100; 75 | — |
| SECONDARY Time to Discharge Readiness at the Postanesthesia Care Unit (PACU) |
67; 60 | — |
| SECONDARY Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg |
60.10; 48.59 | — |
| SECONDARY Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg |
61.07; 50.00 | — |
| SECONDARY Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg |
63.95; 50.00 | — |
| SECONDARY Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg |
65.00; 50.00 | — |
| SECONDARY Average Use of Cardiovascular Drugs: Ephedrine |
20; 15 | — |
| SECONDARY Average Use of Cardiovascular Drugs: Phenylephrine |
0.90; 1.30 | — |
| SECONDARY Average Use of Cardiovascular Drugs: Glycopyrrolate |
0.40; 0.40 | — |
| SECONDARY Average Use of Cardiovascular Drugs: Epinephrine |
1.00; 0.70 | — |
| SECONDARY Average Use of Cardiovascular Drugs: Norepinephrine |
0.62; 0.70 | — |
| SECONDARY Timing of Cardiovascular Drugs for MAP < 65 mmHg |
2; 1.14 | — |
| SECONDARY Timing of Cardiovascular Drugs for MAP < 60 mmHg |
0.8; 1.5 | — |
| SECONDARY Timing of Cardiovascular Drugs for MAP < 55 mmHg |
1; 0.5 | — |
| SECONDARY Timing of Cardiovascular Drugs for MAP < 50 mmHg |
1; 0 | — |
| SECONDARY Intraoperative Administration of Intravenous Fluids |
1500.00; 1400.00 | — |
| SECONDARY Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg |
1.35; 1.27; 0.68; 0.68; 4.10; 2.31 | — |
| SECONDARY Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg |
1.35; 1.25; 0.68; 0.67; 4.36; 2.33 | — |
| SECONDARY Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg |
1.34; 1.25; 0.68; 0.67; 4.60; 4.65 | — |
| SECONDARY Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg |
1.32; 1.23; 0.65; 0.65; 4.28; 4.70 | — |
Summary
The purpose of this study is to determine whether a decision support system can improve the adherence to thresholds for low blood pressure by anesthesia providers, which in turn prevents their patients from having organ injury.
Eligibility Criteria
Inclusion Criteria
- 60 years and older
- Inpatients
- Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia
Exclusion Criteria
- Pre-existing end-stage renal disease: operationalized as a preoperative need for dialysis
- The following surgical procedures: renal surgery, cardiac surgery, organ transplantation, ophthalmic surgery, endoscopic gastrointestinal procedures, and (interventional) radiologic procedures.
- small non-invasive or minimally-invasive procedures will also be excluded, operationalized as excluding procedures with a surgical time of less than twenty minutes.
Data sourced from ClinicalTrials.gov (NCT02726620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.