Liver Transplant; Complications
Conditions
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.
Interventions
OTHERUsual 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.
OTHERUsual Care
Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of Acute Kidney Disfunction | 7 days | Incidence of acute kidney Disfunction according to kdigo criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| re-transplant | 28 days | percentage of re-transplant in 28 days |
| Lenght of Hospitay Stay | 28 days | LOS in 28 days |
| Lenght of ICU Stay | 28 days | ICU LOS 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 |
| Substitutive Renal Therapy | 7 days | percentage of TSR in 7 days |
| 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 |
| Mortality | 28 days | percentage of mortality in 28 days |
| Liver graft primary disfunction ( Initial Poor Function) | 7 days | percentage of Initial Poor Function in 7 days |
| Liver graft primary disfunction (primary nonfunction) | 10 days | percentage of primary nonfunction in 10 days |
| Surgical site infection | 28 days | percentage of SSI 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. |
| Incidence of Arrythmia requiring clinical treatment | 7 days | percentage of Arrhythmia requiring treatment in 7 days |
| MAKE28 | 28 days | Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days) |
Countries
Brazil
Outcome results
None listed