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

NCT ID: NCT04376281

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-15
• Study Completion Date: 2021-10-01

Brief Summary

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

Detailed Description

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 .

Conditions

Liver Transplantation

Keywords

Liver transplantaion , fluid management , noradrenaline

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Noradrenaline group

Group Type: EXPERIMENTAL

Noradrenaline

Intervention Type: DRUG

Noradrenaline infusion for patients undergoing liver transplantaion from living donor .

Interventions

Noradrenaline

Noradrenaline infusion for patients undergoing liver transplantaion from living donor .

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Hussein Sayed

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Mukhtar, MD

Role: STUDY_DIRECTOR

professor

Locations

kasr El Ainy school of medicine

Cairo, , Egypt

Countries

Egypt

References

Rudnick MR, Marchi LD, Plotkin JS. Hemodynamic monitoring during liver transplantation: A state of the art review. World J Hepatol. 2015 Jun 8;7(10):1302-11. doi: 10.4254/wjh.v7.i10.1302.

Reference Type: BACKGROUND

PMID: 26052376 (View on PubMed)

Moller S, Bendtsen F, Henriksen JH. Effect of volume expansion on systemic hemodynamics and central and arterial blood volume in cirrhosis. Gastroenterology. 1995 Dec;109(6):1917-25. doi: 10.1016/0016-5085(95)90759-9.

Reference Type: BACKGROUND

PMID: 7498657 (View on PubMed)

Mukhtar A, Dabbous H. Modulation of splanchnic circulation: Role in perioperative management of liver transplant patients. World J Gastroenterol. 2016 Jan 28;22(4):1582-92. doi: 10.3748/wjg.v22.i4.1582.

Reference Type: BACKGROUND

PMID: 26819524 (View on PubMed)

Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.

Reference Type: BACKGROUND

PMID: 19237896 (View on PubMed)

Other Identifiers

MD.241-2019

Identifier Type: -

Identifier Source: org_study_id