Current partner codePEPTIDESDE
NCT02726620·Not applicable·INTERVENTIONAL

Decision Support for Intraoperative Low Blood Pressure

Status

Completed

Phase

Not applicable

Enrollment

22,435

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

Blood pressure management is an important part of anesthesia. Many factors contribute to a change in blood pressure during a surgical procedure, such as blood loss, manipulation by surgeons, and there are several mechanisms through which anesthesia itself changes blood pressure. Although a high blood pressure also occurs during anesthesia, most of these factors lower a patient's blood pressure. When a patient's blood pressure becomes too low, the internal organs become at risk of receiving not enough blood (low perfusion or hypoperfusion). This low perfusion state can result in organ damage (ischemia) because of an insufficient supply of oxygen and glucose. Hence the important task of anesthesia providers to maintain the blood pressure of patients, using a wide range of drugs and other interventions. A big challenge in blood pressure management is to know when a low blood pressure indeed results in low perfusion of organs. There is a large variation between patients in how susceptible they are to low blood pressure, as well as a difference between the organs in how easily they are damaged because of low perfusion. Elder patients, or patients with preexisting hypertension, heart problems or other cardiovascular diseases are more prone to a low blood pressure and are more likely to develop organ ischemia when there is a low blood pressure. The kidneys, the heart and the brain are the organs that are most at risk of organ damage. As one cannot measure the perfusion states of individual organs in individual patients, it is very difficult to know 'how low to go' with a patient's blood pressure. Recent studies have used large datasets of patients to demonstrate that there is statistical association between low blood pressure during surgery and various types of organ injury. As patients are already treated for low blood pressure by anesthesia providers, this suggests that patients have low organ perfusion states despite the current treatment standards. A patient's blood pressure is not simply a dial that can be adjusted to a specific level. Finding the right level of interventions can be difficult in some patients. Consequently, lower blood pressures are common in anesthesia, even with the current standards of blood pressure management. In this proposed study the investigators will implement two forms of decision support to assist anesthesia providers in blood pressure management. The decision support aims to educate anesthesia providers about the risks of low blood pressures in direct relation to the patients that they treat. One form of decision support will provide automated notifications through pagers and through the anesthesia information management system. These automated notifications pop up when the patient's blood pressure drops below a level that is associated with a risk of organ injury, and thus alerts the anesthesia provider of the blood pressure and its associated risk. The second form of decision support will send a postoperative email the day after the procedure when the patient has had a low blood pressure for particular duration. This email then provides feedback to the anesthesia provider by informing them of the increased risks of organ injury that are associated with that low blood pressure. The study will look at both a change in patient outcome and a change in blood pressure management and will be performed at the Vanderbilt University Medical Center (VUMC). The change in patient outcome will primarily be studied through the occurrence of acute kidney injury in the first days following the procedure at the VUMC. The change in blood pressure management (provider behavior) will be studied by observing the depth and duration of low pressures during anesthesia, and the number of interventions that have been used to treat the blood pressure. Patient outcome will be studied by comparison of a baseline phase - before the decision support is implemented and uses historic data- and the intervention phase - the period during which the intervention is active. Only routinely collected clinical data will be used for these analyses: no additional data collection is required. As it is impossible to know which form of decision support will be the most effective, the first three months of the intervention period will be a 'nested cluster-randomized trial'. The anesthesia providers (not the patients) will be randomized to either the automated notifications or the feedback emails. After three months all anesthesia providers will receive both forms of decision support for the remainder of the intervention period. The reason why anesthesia providers are randomized only during the first three months is that cross-over or contamination between the two groups is expected. This contamination could make it impossible to study the effect of the decision support on patient outcome, as there will be no longer any difference between the study groups.

Interventions

Treatment arms and agents.

PROCEDURE

Attending real-time decision support

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.

PROCEDURE

In-room real-time decision support

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.

PROCEDURE

Attending feedback emails

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.

PROCEDURE

In-room provider feedback emails

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.

DEVICE

Anesthesia Information Management System (AIMS)

The anesthesia electronic record keeping system

DEVICE

Perioperative Data Warehouse (PDW)

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.

PROCEDURE

General anesthesia

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

DEVICE

Pager system

The mobile pager system through which alerts can be sent

PROCEDURE

Central neuraxial anesthesia

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

PROCEDURE

Non-cardiac surgery

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

DRUG

Propofol

Anesthetic drug used to maintain general anesthesia

DRUG

Sevoflurane

Anesthetic drug used to maintain general anesthesia

Timeline

From registration to results.

  1. First posted

    Apr 4, 2016

  2. Study start

    Jan 5, 2017

  3. Primary completion

    Dec 31, 2017

  4. Study completion

    Dec 29, 2018

  5. Results posted

    May 16, 2019

  6. Registry updated

    May 16, 2019

Outcomes

What the study measures.

Primary outcomes

Postoperative Acute Kidney Injury

Time frame · 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 outcomes

30-day Mortality

Time frame · 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)

In-hospital Mortality

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

Hospital mortality rate during a single hospital admission after the surgery

Postoperative Acute Kidney Injury Stage 2

Time frame · 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.

Postoperative Rise in Creatinine Levels

Time frame · 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.

Incidence of a MAP < 60 mmHg

Time frame · 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.

Incidence of a MAP < 55 mmHg

Time frame · 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.

Incidence of a MAP < 50 mmHg

Time frame · 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.

Incidence of a MAP < 60 mmHg for > 10 Minutes

Time frame · 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.

Incidence of a MAP < 55 mmHg for > 10 Minutes

Time frame · 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.

Incidence of a MAP < 50 mmHg for > 10 Minutes

Time frame · 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.

Eligibility

Who can take part.

Minimum age
60 Years
Maximum age
100 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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