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Completed

NCT Number: NCT03572088

Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs

The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure

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Key information

Conditions

Terlipressin Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients older than 18 years of age,
  • ASA classification class I and II,
  • Patients assigned for Whipple procedure.

Exclusion criteria

  • Preoperative renal failure,
  • Severe liver dysfunction (Child-Turcotte-Pugh grade C),
  • Hyponatremia (Na+ <132mmol/l),
  • Severe valvular heart disease,
  • 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 >160/100mmHg despite intensive treatment),
  • Pregnancy.

Treatment and study plan

Terlipressin

Drug

Terlipressin is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation(Terlipressin was 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 received 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. Intraoperative blood loss

    Time frame: intaoperative periods

    Amount of intraoperative blood loss in ml

Secondary outcomes

  1. Patients needing blood transfusion

    Time frame: intaoperative periods

    Number of patients needing blood transfusion

  2. Red blood cell units transfused

    Time frame: intaoperative periods

    The number of red blood cell units transfused

  3. portal pressure changes

    Time frame: intaoperative periods

    portal pressure changes in mmHg

  4. ICU stay

    Time frame: postoperative periods

    ICU stay in days

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2018
Registry last updated
May 22, 2023

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.

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