Renal Perfusion, Filtration and Oxygenation After Liver Transplantation -Effects of av Postoperative Blood Pressure

Not Applicable

Completed

• Conditions: Liver Failure; Acute Kidney Injury
• Interventions: Other: Alternating mean arterial pressure; Drug: Norepinephrine; Drug: Chromium ethylenediaminetetraacetic acid

• Registration Number: NCT02455115
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow, glomerular filtration rate and renal oxygen demand in patients with terminal liver failure directly after liver transplantation.

Detailed Description

Patients with terminal liver failure are at risk to develop postoperative acute kidney injury (AKI) after liver transplantation. This is associated with augmented morbidity (CRRT/HD), and mortality. Hypotension perioperatively is a risk factor for the development of postoperative AKI.

In the investigators' study, the researchers aim to investigate the importance of the level of mean arterial pressure (MAP) on functional renal parameters directly after liver transplantation. 12 patients will be included after given informed and written consent.

Directly after the operation, the patients stay sedated and ventilated, have reached normovolaemia and are in need of vasopressor for adequate blood pressure. MAP is varied using the vasopressor norepinephrine.

Central hemodynamics will be measured using arterial catheter, PiCCO and a central vein catheter.

Renal data measures (RBF (renal blood flow), RPF (renal plasma flow), FF (filtration fraction), GFR (glomerular filtration rate), RVR (renal vascular resistance), Arterial-renal vein oxygen content difference, RVO2 (renal oxygen consumption), and RO2extr (Renal oxygen extraction)), are conducted via a renal vein thermodilution catheter: A 8-Fr catheter is introduced into the left or right renal vein, via the right femoral vein under fluoroscopic guidance, position being confirmed by venography using ultra-low doses of iohexol.

After the collection of blood and urine blanks, an intravenous priming dose of chromium ethylenediaminetetraacetic acid (51Cr-EDTA) is given, followed by an infusion at a constant rate, individualized to BSA and preoperative serum creatinine. Serum 51Cr-EDTA activity from arterial and renal vein blood is measured using a well counter. FF is measured as extraction of Cr-EDTA.

After one hour and two control measurements and urine/blood sampling on baseline MAP 75 mmHg, the investigators will randomise to continue to MAP 90 mmHg or 60 mmHg reached by altering the infusion rate of norepinephrine. Measurements, blood sampling and urine collection according to the above description, are performed after 30 min at each level, finishing at 75 mmHg with two control measurements with 30 mins in between.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Uncomplicated liver transplantation
• Age over 18 years
• Given informed consent preoperatively

Exclusion Criteria

• Veno-venous bypass intraoperatively
• Uncontrolled postoperative bleeding
• Circulatory stability without need for vasopressor treatment
• Pronounced circulatory or respiratory instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
60 mmHg	Alternating mean arterial pressure	Alternating mean arterial pressure by lowering of the infusion rate of norepinephrine
75 mmHg	Chromium ethylenediaminetetraacetic acid	Alternating mean arterial pressure by adjust of the infusion rate of norepinephrine
90 mmHg	Norepinephrine	Alternating mean arterial pressure by augmentation of the infusion rate of norepinephrine
75 mmHg	Alternating mean arterial pressure	Alternating mean arterial pressure by adjust of the infusion rate of norepinephrine
60 mmHg	Chromium ethylenediaminetetraacetic acid	Alternating mean arterial pressure by lowering of the infusion rate of norepinephrine
90 mmHg	Alternating mean arterial pressure	Alternating mean arterial pressure by augmentation of the infusion rate of norepinephrine
90 mmHg	Chromium ethylenediaminetetraacetic acid	Alternating mean arterial pressure by augmentation of the infusion rate of norepinephrine
60 mmHg	Norepinephrine	Alternating mean arterial pressure by lowering of the infusion rate of norepinephrine
75 mmHg	Norepinephrine	Alternating mean arterial pressure by adjust of the infusion rate of norepinephrine

Primary Outcome Measures

Name	Time	Method
Change in Glomerular filtration rate (ml/min)	60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again	Change from baseline 75 mmHg to 60 and 90 mmHg, respectively

Secondary Outcome Measures

Name	Time	Method
Change in Renal blood flow (ml/min)	60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again	Measured via retrograde thermodilution catheter placed in renal vein. Change from baseline 75 mmHg to 60 and 90 mmHg, respectively.
Change in Renal oxygen consumption (ml/min)	60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again	Blood samples and measurements of blood flow via retrograde thermodilution catheter placed in renal vein.; RBF × (CaO2-CrvO2) Change from baseline 75 mmHg to 60 and 90 mmHg, respectively
Change in Filtration fraction (%)	60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again	Extraction of Cr-EDTA, blood samples from renal vein catheter. Change from baseline 75 mmHg to 60 and 90 mmHg, respectively.
Change in Renal oxygen supply/demand relationship	60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again	Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2). Change from baseline 75 mmHg to 60 and 90 mmHg, respectively.

Trial Locations

Locations (1)

Sahlgrenska University Hospital, dpt of anesthesiology and intensive care; 🇸🇪 Göteborg, VGR, Sweden