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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Transplant; Complications

Intervention / Treatment
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* Other: Usual Care + High Target of Mean Arterial Pressure
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hihg Target Mean Arterial Pressure<br>Target of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant. | Other: Usual Care + High Target of Mean Arterial Pressure<br>* Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.<br>|
| Active Comparator: Low Target Mean Arterial Pressure<br>Target of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant. | Other: Usual Care<br>* Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Acute Kidney Disfunction | Incidence of acute kidney Disfunction according to kdigo criteria. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | percentage of mortality in 28 days | 28 days | 
| re-transplant | percentage of re-transplant in 28 days | 28 days | 
| Lenght of Hospitay Stay | LOS in 28 days | 28 days | 
| Lenght of ICU Stay | ICU LOS in 28 days | 28 days | 
| Days alive and out of hospital in 28 days | Number of days alive and out of hospital in 28 days | 28 days | 
| Substitutive Renal Therapy | percentage of TSR in 7 days | 7 days | 
| Days Alive and free of renal disfunction | Days Alive and free of renal disfunction in 28 days | 28 days | 
| 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 | 
| MAKE28 | Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days) | 28 days | 
| Liver graft primary disfunction ( Initial Poor Function) | percentage of Initial Poor Function in 7 days | 7 days | 
| Liver graft primary disfunction (primary nonfunction) | percentage of primary nonfunction in 10 days | 10 days | 
| Surgical site infection | percentage of SSI in 28 days | 28 days | 
| Need of Transfusion | percentage of Transfusion requirement in 7 days | 7 days | 
| 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 | 
| Incidence of Arrythmia requiring clinical treatment | percentage of Arrhythmia requiring treatment in 7 days | 7 days |