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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376281
• Other study ID #: MD.241-2019
• Status: Completed
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Noradrenaline
Noradrenaline infusion for patients undergoing liver transplantaion from living donor .

Locations

Country	Name	City	State
Egypt	kasr El Ainy school of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Møller 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Noradrenaline on change of cardiac output .	The effect of Noradrenaline on change of cardiac output .	along the procedure ; from skin incision to the end of surgery
Secondary	The effect of NE on mean systemic filling pressure .	The effect of NE on mean systemic filling pressure .	along the procedure ; from skin incision to the end of surgery
Secondary	The effect of NE on venous return .	The effect of NE on venous return .	along the procedure ; from skin incision to the end of surgery
Secondary	The effect of NE on central venous pressure .	The effect of NE on central venous pressure .	along the procedure ; from skin incision to the end of surgery