High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.

Liver Transplant; Complications Clinical Trial

— LIVER-PAM  

Official title:

High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05068713
• Other study ID #: LIVER-PAM
• Status: Completed
• Phase: Phase 3
• Start date: August 24, 2021
• Est. completion date: January 5, 2024

Study information

• Verified date: January 2024
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

LIVER PAM

A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18 y

• Admitted in the ICU for a post operative care after liver transplant

Exclusion Criteria:

• Consent refusal

• Liver transplant due to acute liver failure

• Renal transplant ( Previous or concomitant)

• Refusal from the healthcare provider responsible for the patient

• Renal substitution therapy in the prior 15 days

• Pregnancy

• Re-Transplant (Liver transplant in the previous 6 month)

• Hepatorenal syndrome current treatment (Use of terlipressin + Albumin)

• Refractory and persistent shock during or after transplant

Related Conditions & MeSH terms

• Hypotension
• Liver Transplant; Complications

Intervention

Other:
• Usual Care + High Target of Mean Arterial Pressure
Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.
• Usual Care
Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.

Locations

Country	Name	City	State
Brazil	Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo	São Paulo	SAO Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of Acute Kidney Disfunction	Incidence of acute kidney Disfunction according to kdigo criteria.	7 days
Secondary	Mortality	percentage of mortality in 28 days	28 days
Secondary	re-transplant	percentage of re-transplant in 28 days	28 days
Secondary	Lenght of Hospitay Stay	LOS in 28 days	28 days
Secondary	Lenght of ICU Stay	ICU LOS in 28 days	28 days
Secondary	Days alive and out of hospital in 28 days	Number of days alive and out of hospital in 28 days	28 days
Secondary	Substitutive Renal Therapy	percentage of TSR in 7 days	7 days
Secondary	Days Alive and free of renal disfunction	Days Alive and free of renal disfunction in 28 days	28 days
Secondary	Acute kidney insufficiency according to Urinary NGAL on d0 and D2	Percentage of renal disfunction according to NGAL criteria on D0 and D2	0d and 2d
Secondary	MAKE28	Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days)	28 days
Secondary	Liver graft primary disfunction ( Initial Poor Function)	percentage of Initial Poor Function in 7 days	7 days
Secondary	Liver graft primary disfunction (primary nonfunction)	percentage of primary nonfunction in 10 days	10 days
Secondary	Surgical site infection	percentage of SSI in 28 days	28 days
Secondary	Need of Transfusion	percentage of Transfusion requirement in 7 days	7 days
Secondary	Postoperative Major bleeding in 7 days	Bleeding that requires 2 units of blood transfusion in a single day or the need of a reoperation due to bleeding in the first 24 hours after surgery.	7 days
Secondary	Incidence of Arrythmia requiring clinical treatment	percentage of Arrhythmia requiring treatment in 7 days	7 days