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

Phase 3

Completed

• Conditions: Liver Transplant; Complications
• Interventions: Other: Usual Care + High Target of Mean Arterial Pressure; Other: Usual Care

• Registration Number: NCT05068713
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-24
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-06
• Status Verified: 2024-01
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hihg Target Mean Arterial Pressure	Usual Care + High Target of Mean Arterial Pressure	Target of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant.
Low Target Mean Arterial Pressure	Usual Care	Target of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant.

Primary Outcome Measures

Name	Time	Method
incidence of Acute Kidney Disfunction	7 days	Incidence of acute kidney Disfunction according to kdigo criteria.

Secondary Outcome Measures

Name	Time	Method
Lenght of Hospitay Stay	28 days	LOS in 28 days
Substitutive Renal Therapy	7 days	percentage of TSR in 7 days
MAKE28	28 days	Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days)
Lenght of ICU Stay	28 days	ICU LOS in 28 days
re-transplant	28 days	percentage of re-transplant in 28 days
Days alive and out of hospital in 28 days	28 days	Number of days alive and out of hospital in 28 days
Mortality	28 days	percentage of mortality in 28 days
Need of Transfusion	7 days	percentage of Transfusion requirement in 7 days
Postoperative Major bleeding in 7 days	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.
Days Alive and free of renal disfunction	28 days	Days Alive and free of renal disfunction in 28 days
Acute kidney insufficiency according to Urinary NGAL on d0 and D2	0d and 2d	Percentage of renal disfunction according to NGAL criteria on D0 and D2
Liver graft primary disfunction (primary nonfunction)	10 days	percentage of primary nonfunction in 10 days
Liver graft primary disfunction ( Initial Poor Function)	7 days	percentage of Initial Poor Function in 7 days
Incidence of Arrythmia requiring clinical treatment	7 days	percentage of Arrhythmia requiring treatment in 7 days
Surgical site infection	28 days	percentage of SSI in 28 days

Trial Locations

Locations (1)

Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo; 🇧🇷 São Paulo, SAO Paulo, Brazil