Decision Support for Intraoperative Low Blood Pressure

NCT02726620 | Completed Results

• 1 other identifier: 160131
• Study Type: interventional
• Target: 22,435
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension

Keywords

Decision support; Decision Support Systems, Clinical; Decision Support Techniques; Hypotension; Intraoperative Hypotension; Acute Kidney Injury; Postoperative Mortality; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Postoperative Acute Kidney Injury

  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.

  Within 7 days after surgery

Secondary Outcomes (39)

• 30-day Mortality

  30 days after surgery

• In-hospital Mortality

  All postoperative days during a single hospital admission, expected median of 5 days

• Postoperative Acute Kidney Injury Stage 2

  Within 7 days after surgery

• Postoperative Rise in Creatinine Levels

  Within 7 days after surgery

• Incidence of a MAP < 60 mmHg

  During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Study Arms (2)

Hypotension decision support

EXPERIMENTAL

The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.

Procedure: Attending real-time decision support; Procedure: In-room real-time decision support; Procedure: Attending feedback emails; Procedure: In-room provider feedback emails; Device: Anesthesia Information Management System (AIMS); Device: Perioperative Data Warehouse (PDW); Procedure: General anesthesia; Device: Pager system; Procedure: Central neuraxial anesthesia; Procedure: Non-cardiac surgery; Drug: 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

Usual care group

ACTIVE COMPARATOR

The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).

Procedure: General anesthesia; Procedure: Central neuraxial anesthesia; Procedure: Non-cardiac surgery; Drug: 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

Interventions

Attending real-time decision support PROCEDURE

Near real-time decision support elements will notify the attending anesthesiologists of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the pager system. The page will also display the associated increased risk of organ injury due to organ ischemia.

Hypotension decision support

In-room real-time decision support PROCEDURE

Near real-time decision support elements will notify the in-room anesthesia provider of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the anesthesia information management system. The decision support system will display the associated increased risk of organ injury due to organ ischemia.

Hypotension decision support

Attending feedback emails PROCEDURE

Attending anesthesiologists will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.

Hypotension decision support

In-room provider feedback emails PROCEDURE

In-room anesthesia providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.

Hypotension decision support

Anesthesia Information Management System (AIMS) DEVICE

The anesthesia electronic record keeping system

Hypotension decision support

Perioperative Data Warehouse (PDW) DEVICE

The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the postoperative feedback emails.

Hypotension decision support

General anesthesia PROCEDURE

Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.

Hypotension decision support; Usual care group

Pager system DEVICE

The mobile pager system through which alerts can be sent

Hypotension decision support

Central neuraxial anesthesia PROCEDURE

Regional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia.

Also known as: Regional anesthesia, Spinal anesthesia, Intrathecal anesthesia, Subarachnoid anesthesia, Epidural anesthesia, Central neuraxial blockade

Hypotension decision support; Usual care group

Non-cardiac surgery PROCEDURE

Any surgical intervention that is not aimed at surgical correction of the heart

Hypotension decision support; Usual care group

Propofol DRUG

Anesthetic drug used to maintain general anesthesia

Hypotension decision support; Usual care group

Sevoflurane DRUG

Anesthetic drug used to maintain general anesthesia

Hypotension decision support; Usual care group

Desflurane DRUG

Anesthetic drug used to maintain general anesthesia

Hypotension decision support; Usual care group

Isoflurane DRUG

Anesthetic drug used to maintain general anesthesia

Hypotension decision support; Usual care group

Ephedrine DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Phenylephrine DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Norepinephrine DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Epinephrine DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Dobutamine DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Dopamine DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Isoproterenol DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Milrinone DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Atropine DRUG

Cardiovascular drugs used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Glycopyrrolate DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Vasopressin DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Terlipressin DRUG

Cardiovascular drug used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Sodium Chloride 0.9% DRUG

Intravenous fluid used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Ringer's lactate DRUG

Intravenous fluid used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Hydroxyethyl starch solutions DRUG

Intravenous fluid used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Fresh Frozen Plasma DRUG

Intravenous fluid used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Packed Red Blood Cells DRUG

Intravenous fluid used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Albumin solutions DRUG

Intravenous fluid used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Plasma-Lyte DRUG

Intravenous fluid used to treat intraoperative hypotension

Hypotension decision support; Usual care group

Lidocaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Also known as: Lignocaine

Hypotension decision support; Usual care group

Bupivacaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Levobupivacaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Ropivacaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Mepivacaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Tetracaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Prilocaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Procaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Chloroprocaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Benzocaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Articaine DRUG

Local anesthetic used for central neuraxial anesthesia.

Hypotension decision support; Usual care group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Inpatients
• Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• UMC Utrecht: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Hypotension; Acute Kidney Injury

Interventions

Anesthesia, General; Anesthesia, Conduction; Anesthesia, Spinal; Anesthesia, Epidural; Propofol; Sevoflurane; Desflurane; Isoflurane; Ephedrine; Phenylephrine; Norepinephrine; Epinephrine; Dobutamine; Dopamine; Isoproterenol; Milrinone; Atropine; Glycopyrrolate; Vasopressins; Terlipressin; Sodium Chloride; Ringer's Lactate; Plasma-lyte 148; Lidocaine; Bupivacaine; Levobupivacaine; Ropivacaine; Mepivacaine; Tetracaine; Prilocaine; Procaine; chloroprocaine; Benzocaine; Carticaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Ethyl Ethers; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Amrinone; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Lypressin; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Aniline Compounds; Piperidines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Thiophenes; Sulfur Compounds

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').

Results Point of Contact

• Title: Jonathan Wanderer
• Organization: Vanderbilt University Medical Center

jon.wanderer@vanderbilt.edu

615-536-5194

Study Officials

• Jonathan P Wanderer, MD, MPhil

  Vanderbilt University Medical Center, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Procedure Preparation Center

Model Details: It is an interrupted time-series of a decision support package intervention that aims to study the the effect of the decision support package on patient outcome. The effects of the individual decision support components of the package on healthcare provider behavior will be studied in a nested cluster-randomized trial: in the first month the attending anesthesiologists will be randomized to near-realtime notifications or feedback emails; in the second month in-room providers will be randomized to near-realtime notifications or feedback emails. Starting month four all providers will receive both near-realtime notifications and feedback emails.

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 4, 2016
• Study Start: January 5, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 29, 2018
• Last Updated: May 16, 2019
• Results First Posted: May 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)