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Completed

NCT Number: NCT04376281

The Effect of Norepinephrine on Cardiac Output in Patients Undergoing Liver Transplant .

Early administration of NE in liver transplant recipient might enhance cardiac output through an increase in cardiac preload .

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

kasr El Ainy school of medicine

Cairo, 11211, Egypt

About this study

The derangement of circulatory blood volume in patients with liver cirrhosis makes intraoperative fluid management during liver transplant is challenging . Cirrhotic patients not only have large blood volume but abnormal blood volume distribution, with a substantial fraction of this volume in the splanchnic circulation (. These hemodynamic changes render volume loading in these patients has little impact on CO because a large proportion of infused fluid is shifted to the splanchnic system . In addition, patients with liver cirrhosis is similar to septic patients who have increased total vascular compliance which may cause pooling of blood in venous pool. Several studies in patients with sepsis found that use of low dose vasopressor may convert unstressed blood volume (i.e the amount of blood not causing pressure on the vessels) to stressed volume (i.e additional blood causing a distending pressure on the vascular walls and reflects the effective circulating volume) . However, no previous studies tested the effect of using norepinephrine (NE) on venous return and cardiac preload in patients undergoing liver transplant. An obvious advantage of this possibility is that NE will be used instead of true fluid replacement which may minimize fluid replacement during operation.

Recently, a method was described to estimate the changes in intravascular volume and vascular capacitance by calculating mean systemic filling pressure (MSFP) . MSFP is the driving pressure in venous return, and it allows calculation of the arterial and venous components of systemic vascular resistance .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All Adults (age > 18 years) patients undergoing living donor liver transplant (LDLT) will be considered for inclusion in the study..

Exclusion criteria

  • Patients less than 18 years.
  • Patients undergoing liver transplantation for acute liver failure .
  • All Chronic Hypertensive patients on medication , whether controlled on not controlled
  • Those with high risk of post transplant renal dysfunction (serum creatinine >1.5 mg/dL at time of transplant)

Treatment and study plan

Noradrenaline

Drug

Noradrenaline infusion for patients undergoing liver transplantaion from living donor .

Primary outcomes

  1. The effect of Noradrenaline on change of cardiac output .

    Time frame: along the procedure ; from skin incision to the end of surgery

    The effect of Noradrenaline on change of cardiac output .

Secondary outcomes

  1. The effect of NE on mean systemic filling pressure .

    Time frame: along the procedure ; from skin incision to the end of surgery

    The effect of NE on mean systemic filling pressure .

  2. The effect of NE on venous return .

    Time frame: along the procedure ; from skin incision to the end of surgery

    The effect of NE on venous return .

  3. The effect of NE on central venous pressure .

    Time frame: along the procedure ; from skin incision to the end of surgery

    The effect of NE on central venous pressure .

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Norepinephrine on Blood Volume Cardiac , Output and Systemic Filling Pressure in Patients Undergoing Liver Transplant .

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 6, 2020
Registry last updated
Nov 9, 2021

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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