Decision Support for Intraoperative Low Blood Pressure

What Was Tested

In this not phased trial, researchers set out to test Terlipressin for low blood pressure and orthostatic hypotension.

It had two arms (groups): Hypotension decision support (experimental) and 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).

The registry classes the interventions as device, drug and procedure.

More on the Plan

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).

Who Took Part

Enrollment: 22435 actual participants took part.

It was open to people of any sex aged from 60 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 60 years and older. Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: non-randomized, sequential and open-label.

Being open-label, the Terlipressin study did not mask who received what.

It started in 2017-01-05 with completion listed for 2017-12-31.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Postoperative Acute Kidney Injury (time frame: Within 7 days after surgery).

It also tracked 39 secondary outcomes, for example 30-day Mortality, In-hospital Mortality, Postoperative Acute Kidney Injury Stage 2, Postoperative Rise in Creatinine Levels, Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg and Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Terlipressin in 22435 people with low blood pressure and orthostatic hypotension.

With 22435 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Terlipressin compound page, Low blood pressure and orthostatic hypotension research.