Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery
NCT ID: NCT02718599
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2016-04-30
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Terlipressin
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.
terlipressin
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.
CONTROL
Patients receive the same volume of 0.9% saline in place of terlipressin for the same duration(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).
normal 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.
Interventions
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terlipressin
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.
normal 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any gender.
* ASA (American Society of Anesthesiologists) Classification( Class I-II)
* Patients undergoing major elective hepatobiliary surgery.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Magdy Mohammed Mahdy Sayed
Effect of terlipressin and hepatic hemodynamics during hepatobiliary surgery infusion on systemic.
Principal Investigators
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Mostafa Samy
Role: STUDY_DIRECTOR
Assiut University
Locations
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Assiut University hospital
Asyut, Asyut Governorate, Egypt
Countries
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References
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Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.
Other Identifiers
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ABC-123-DE
Identifier Type: -
Identifier Source: org_study_id