Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06756672

HPI in Laparoscopic Colorectal Surgery

Using the Hypotension Prediction Index in patients undergoing laparoscopic colorectal surgery, including data from National Taiwan University Hospital and Taipei Veterans General Hospital

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital and Taipei Veterans General Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Chien-Kun Ting, MD, PhD

CONTACT

[email protected]

Chih-Jun Lai, MD, PhD

CONTACT

[email protected]

About this study

Intraoperative hypotension is a common occurrence during laparoscopic colorectal cancer resection, often attributable to factors such as general anesthesia, the growing population of elderly patients, and the use of pneumoperitoneum during surgery. This condition, defined as a mean arterial pressure (MAP) below 65 mmHg, is linked to major organ complications within 30 days postoperatively. Introduced in 2019, the Hypotension Prediction Index (HPI) is an algorithm designed to predict the onset of intraoperative hypotension. Previous studies have used the time-weighted average MAP below 65 mmHg as a primary endpoint, calculated as the area under the MAP curve <65 mmHg (mmHg × hours) divided by the duration of surgery (hours), with a value ≥0 indicating severity. Higher values reflect more severe hypotension. However, research on the application of HPI in laparoscopic colorectal cancer resection remains limited. This study aims to determine whether the use of HPI can reduce the severity of intraoperative hypotension in patients undergoing laparoscopic colorectal cancer resection and whether it can decrease the incidence of major postoperative organ complications. A total of 120 patients, aged 20-80 years and undergoing elective laparoscopic colorectal cancer resection, will be randomly assigned to two groups: an intervention group guided by HPI and a control group without HPI guidance. In the intervention group, an alert will be triggered when the HPI exceeds 85, indicating a potential MAP drop below 65 mmHg, whereas the control group will initiate hypotension treatment only when MAP falls below 65 mmHg. Both groups will adhere to the same intraoperative hypotension management protocols, including fluid resuscitation, vasopressor administration, and observation. The primary treatment outcome will be the time-weighted average MAP <65 mmHg, and major postoperative organ complications will be monitored for 30 days post-surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing elective laparoscopic colorectal surgery

Exclusion criteria

  • Severe heart or lung diseases

Treatment and study plan

HPI guidance

Device

patients with HPI guidance

No HPI guidance

Device

patients without HPI guidance

Primary outcomes

  1. time weighted average mean arterial pressure (TWA MAP) <65 mmHg (unit: mmHg)

    Time frame: during the whole surgery

    the severity and duration of hypotension

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Kun Ting, MD, PhD

CONTACT

[email protected]

Chih-Jun Lai, MD, PhD

CONTACT

[email protected]

+886-965327939

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Hypotension Prediction Index for Prevention of Hypotension and Postoperative Complications During Laparoscopic Surgery for Colorectal Cancer: A Multi-Center Randomized Trial

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Jan 3, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.