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Completed

NCT Number: NCT02718599

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

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

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Key information

Conditions

Hemodynamics, Liver, Terlipressin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Terlipressin

Drug

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.

Other names: glypressin

normal saline

Drug

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.

Other names: 0.9 Nacl

Primary outcomes

  1. portal pressure changes

    Time frame: intraoperative period

    portal pressure changes in mmHg

Secondary outcomes

  1. Effect on systemic vascular resistance

    Time frame: intraoperative period

    •Effect on systemic vascular resistance in dyne.s/cm5

  2. Renal impairment

    Time frame: for 3 days in the postoperative period

    Number of patients with renal impairment [defined as at least a doubling of serum creatinine or oliguria (<500 mL/24 hours)].

  3. Blood units transfused

    Time frame: intraoperative period

    Number of packed RBCs (red blood cells) units transfused

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2016
Registry last updated
Dec 19, 2017

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.