NCT03441035

Brief Summary

This clinical observational cohort study assess the loss of albumin from blood circulation during and after liver transplantation by mass balance of albumin. The overall assumption of this method is that if albumin is more diluted than hemoglobin, it must have left the plasma, presumably into the interstitial space. Predictors of albumin leakage will be assessed, including biomarkers of inflammation and of endothelial damage and dysfunction. The sub cohorts children and patients with complications, defined as prolonged postoperative treatment in the intensive care unit, respectively, will be focused in separate publications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

February 15, 2018

Last Update Submit

September 2, 2020

Conditions

Liver Transplant; ComplicationsFluid Overload

Outcome Measures

Primary Outcomes (1)

  • Cumulative perioperative shift of albumin

    By mass balance of albumin (i.e keeping track of all gains and losses of albumin and compare these to hemoglobin) it is possible to estimate the loss of albumin from plasma that is not explained by losses in bleeding or drains.

    Post-operative day 7 after liver transplantation

Secondary Outcomes (4)

  • Predictors of cumulative perioperative shift of albumin

    from pre-operative risk assessment until post-operative day 7

  • Predictors of prolonged need for ICU stay

    from pre-operative risk assessment until post-operative day 21

  • Albumin synthesis rate

    postoperative days 3-21 after liver transplantation

  • Cumulative perioperative shift of albumin in children

    during and after liver transplantation until postoperative day 21

Study Arms (3)

Adults, uncomplicated

Adults undergoing liver transplantation. Mass balance of albumin will be undertaken by sampling of albumin in plasma and in all fluids that is infused or lost from the body to keep track of albumin and hemoglobin changes until postoperative day 7. B-Hb is taken routinely and not study specific samples. Plasma for ELISAs is taken at 2-3 time points.

Other: General anesthesia and surgery (liver transplantation)

Adults, complicated

Adults undergoing liver transplantation. Mass balance of albumin will be undertaken by sampling of albumin in plasma and in all fluids that is infused or lost from the body to keep track of albumin and hemoglobin changes until hospital discharge or postoperative day 21. B-Hb is taken routinely and not study specific samples. Plasma for ELISAs is taken at 2-3 time points. A infusion of deuterium labeled phenylalanine will be given in the ICU at 1-3 occasions to determine the synthesis rate of albumin.

Other: General anesthesia and surgery (liver transplantation)

Children

Children undergoing liver transplantation. Mass balance of albumin will be undertaken by sampling of albumin in in all fluids that is infused or lost from the body to keep track of albumin and hemoglobin changes until postoperative day 7. P-albumin and B-Hb is only taken routinely and not study specific samples. Plasma for ELISAs is taken at 2-3 time points.

Other: General anesthesia and surgery (liver transplantation)

Interventions

General anesthesia and surgery (liver transplantation)OTHER

The effects of general anesthesia and surgery under the hospital routine of albumin administration during and after liver transplantation is studied with the mass balance of albumin method.

Adults, complicatedAdults, uncomplicatedChildren

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing liver transplantation at our unit (approximately 85 patients per year) will be asked to participate.

You may qualify if:

  • All patients undergoing liver transplantation are eligible

You may not qualify if:

  • No consent Unability to understand the study information (language or consciousness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Huddinge

Huddinge, 14186, Sweden

RECRUITING

Related Publications (3)

  • Fleck A, Raines G, Hawker F, Trotter J, Wallace PI, Ledingham IM, Calman KC. Increased vascular permeability: a major cause of hypoalbuminaemia in disease and injury. Lancet. 1985 Apr 6;1(8432):781-4. doi: 10.1016/s0140-6736(85)91447-3.

    PMID: 2858667BACKGROUND

  • Norberg A, Rooyackers O, Segersvard R, Wernerman J. Leakage of albumin in major abdominal surgery. Crit Care. 2016 Apr 26;20(1):113. doi: 10.1186/s13054-016-1283-8.

    PMID: 27117323BACKGROUND

  • Ballmer PE, McNurlan MA, Milne E, Heys SD, Buchan V, Calder AG, Garlick PJ. Measurement of albumin synthesis in humans: a new approach employing stable isotopes. Am J Physiol. 1990 Dec;259(6 Pt 1):E797-803. doi: 10.1152/ajpendo.1990.259.6.E797.

    PMID: 2260648BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for determination of P-albumin, Plasma for determination of markers of inflammation and endothelial dysfunction or injury (such as interleukine 6, syndecan, heparin-binding protein), X-albumin to be determined in urine, succion bottles, drains, and any albumin containing intravenous infusion.

MeSH Terms

Conditions

Edema

Interventions

Anesthesia, GeneralSurgical Procedures, OperativeLiver Transplantation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresOrgan TransplantationTransplantation

Study Officials

  • Åke Norberg, Ass Prof

    Perioperative Medicine and Intensive Care, Karolinska University Hospital Huddinge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Åke Norberg, Ass Prof

CONTACT

+46739661152ake.norberg@sll.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, Senior Consultant

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 22, 2018

Study Start

March 27, 2018

Primary Completion

February 28, 2021

Study Completion

June 30, 2021

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)