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

NCT02455115 | Completed

• 1 other identifier: MAP after Livertransplantation
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Liver Failure

Keywords

Acute kidney injury; Liver transplantation; Postoperative care; Glomerular filtration rate; Renal blood flow; Vasopressor; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• Change in Glomerular filtration rate (ml/min)

  Change from baseline 75 mmHg to 60 and 90 mmHg, respectively

  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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

60 mmHg

EXPERIMENTAL

Alternating mean arterial pressure by lowering of the infusion rate of norepinephrine

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

75 mmHg

EXPERIMENTAL

Alternating mean arterial pressure by adjust of the infusion rate of norepinephrine

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

90 mmHg

EXPERIMENTAL

Alternating mean arterial pressure by augmentation of the infusion rate of norepinephrine

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

Interventions

Alternating mean arterial pressure OTHER

In normovolemic patients directly after liver transplantation, target mean arterial pressure is altered using norepinephrine according to study protocol.

Also known as: Norepinephrine

60 mmHg; 75 mmHg; 90 mmHg

Norepinephrine DRUG

Infusion rate of norepinephrine is raised and lowered, respectively, in order to reach MAP 60, 75 and 90 mmHg in patients already requiring vasopressor for adequate blood pressure control.

Also known as: Blood pressure control

60 mmHg; 75 mmHg; 90 mmHg

Chromium ethylenediaminetetraacetic acid DRUG

Extraction of 51Cr-EDTA measured for FF and GFR

Also known as: Infusion of 51Cr-EDTA

60 mmHg; 75 mmHg; 90 mmHg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital, dpt of anesthesiology and intensive care

Gothenburg, VGR, 41345, Sweden

Location

Related Publications (1)

• Skytte Larsson J, Bragadottir G, Redfors B, Ricksten SE. Renal function and oxygenation are impaired early after liver transplantation despite hyperdynamic systemic circulation. Crit Care. 2017 Apr 11;21(1):87. doi: 10.1186/s13054-017-1675-4.

  PMID: 28395663 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Liver Failure

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jenny Skytte Larsson, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

• Sven-Erik Ricksten, Professor

  Sahlgrenska University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 27, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

SE (1)