NCT04966364

Hypotension Prediction Index in Major Gastrointestinal Surgery

Completed NA Last updated 25 July 2022

What this trial tests

NA trial testing hypotension prediction index guided in the Effect of Hypotension Prediction Index Application in 60 participants. Completed in 6 March 2022.

Timeline

22 July 2021

Primary endpoint
27 January 2022

6 March 2022

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	other
Enrollment	60
Start date	22 July 2021
Primary completion	27 January 2022
Estimated completion	6 March 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• hypotension prediction index guided
• without hypotesion prediction index guided

Conditions studied

• the Effect of Hypotension Prediction Index Application — all drugs for the Effect of Hypotension Prediction Index Application →

Sponsor

National Taiwan University Hospital

Who can join

Adults 20 to 80, any sex, with the Effect of Hypotension Prediction Index Application. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intraoperative hypotension (IOH) is defined as a mean arterial pressure (MAP) of \< 65mmHg during surgery. Patients undergoing major gastrointestinal (GI) surgery, such as esophagectomy with reconstruction, are at a high-risk of IOH because such surgeries typically require more than 3h to complete and require blood transfusion or inotrope administration. Critically, these surgeries involve organ removal or substitute connection, which require wound or flap anastomosis. IOH is believed to be associated with postoperative anastomosis necrosis. It increases the risk of postoperative intrathoracic or abdominal infection, resulting in septic shock, postoperative major organ dysfunction and mortality.

The data of TWA-MAP\< 65mmHg in the HPI guidance group will be significantly lower than that in the group without HPI guidance.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hypotension prediction index for prevention of intraoperative hypotension in patients undergoing general anesthesia: a randomized controlled trial.
   Lai CJ, Cheng YJ, Han YY, Hsiao PN, et al · · 2024 · cited 7× · PMID 38879506 · DOI 10.1186/s13741-024-00414-7
2. Hypotension Prediction Index for Prevention of Intraoperative Hypotension in Patients Undergoing General Anesthesia: A Randomized Controlled Trial
   Lai C, Cheng Y, Han Y, Hsiao P, et al · · 2023 · DOI 10.21203/rs.3.rs-3350451/v1