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Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02718599
Enrollment
50
Registered
2016-03-24
Start date
2016-04-30
Completion date
2017-07-31
Last updated
2017-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamics, Liver, Terlipressin

Brief summary

To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery

Interventions

DRUGterlipressin

Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.

DRUGnormal saline

Patients receive 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years. * Any gender. * ASA (American Society of Anesthesiologists) Classification( Class I-II) * Patients undergoing major elective hepatobiliary surgery.

Exclusion criteria

* Preoperative renal failure (GFR \< 50 ml/min). * Severe liver dysfunction (Child- turcotte -Pugh grade C). * Hyponatremia (\<132 mmol/l). * Severe aortic regurgitation, severe mitral regurgitation, heart failure. * Symptomatic coronary heart disease. * Bradycardic arrhythmia (heart rate \< 60/min). * Peripheral artery occlusive disease (clinical stadium II-IV). * Uncontrolled arterial hypertension (Blood pressure \>160/100 mmHg despite intensive treatment). * Pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
portal pressure changesintraoperative periodportal pressure changes in mmHg

Secondary

MeasureTime frameDescription
Effect on systemic vascular resistanceintraoperative period•Effect on systemic vascular resistance in dyne.s/cm5
Renal impairmentfor 3 days in the postoperative periodNumber of patients with renal impairment \[defined as at least a doubling of serum creatinine or oliguria (\<500 mL/24 hours)\].
Blood units transfusedintraoperative periodNumber of packed RBCs (red blood cells) units transfused

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026