Status:
NOT_YET_RECRUITING
Hypotension Prediction Index and Intraoperative Hypotension Incidence
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Intraoperative Hypotension
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This study aim to implement intraoperative hemodynamic monitoring and management guided with HPI algorithm in frail patients undergoing elective abdominal surgery. Investigators hypothesize that the u...
Detailed Description
Intraoperative hypotension (IOH) is common, a study involved 34,045 surgical patients in elective, emergency, and intensive care unit (ICU) found that the incidence of hypotension (defined as systolic...
Eligibility Criteria
Inclusion
- Age\> 60 years old
- Frail score \> 2
- ASA≥2
- Planned to receive general anesthesia
- Elective laparoscopic or laparotomy major abdominal surgery with an expected duration of \> 180 minutes
- Planned to receive an arterial line monitoring intraoperatively
- Being able to give written informed consent prior to surgery
Exclusion
- Severe cardiac arrhythmia including atrial fibrillation
- Severe aortic stenosis
- Uncontrolled Hypertension (sitting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg during screening)
- Significant hypotension before surgery defined as a MAP \<65mmHg
- Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease
- Organ transplant surgery, surgery involving the kidney, liver surgery requiring hilar blockage, surgery requiring controlled hypotension or controlled low central venous pressure
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06909786
Start Date
April 1 2025
End Date
December 31 2025
Last Update
April 4 2025
Active Locations (1)
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1
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061