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

Information source: Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Kidney Injury; Liver Failure

Intervention: Alternating mean arterial pressure (Other); Norepinephrine (Drug); Chromium ethylenediaminetetraacetic acid (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Sahlgrenska University Hospital, Sweden

Official(s) and/or principal investigator(s):
Jenny Skytte Larsson, MD, Principal Investigator, Affiliation: Sahlgrenska University Hospital, Sweden
Sven-Erik Ricksten, Professor, Study Chair, Affiliation: Sahlgrenska University Hospital, Sweden

Overall contact:
Jenny Skytte Larsson, MD, Phone: 0046-706964800, Email: jenny.skytte@vgregion.se

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Glomerular filtration rate (ml/min)

Secondary outcome:

Change in Renal blood flow (ml/min)

Change in Renal oxygen consumption (ml/min)

Change in Filtration fraction (%)

Change in Renal oxygen supply/demand relationship

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Jenny Skytte Larsson, MD, Phone: 0046-706964800, Email: jenny.skytte@vgregion.se

Sahlgrenska University Hospital, dpt of anesthesiology and intensive care, Göteborg, VGR 41345, Sweden; Recruiting
Jenny Skytte Larsson, MD
Additional Information

Starting date: January 2015
Last updated: May 26, 2015

Page last updated: August 23, 2015

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