NCT03453320

Brief Summary

Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine. One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known. In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 24, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

February 24, 2018

Last Update Submit

May 25, 2019

Conditions

Edema Secondary

Outcome Measures

Primary Outcomes (1)

  • Plasma volume

    Albumin infusion expands the plasma volume and dilutes hemoglobin. The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.

    6 hours

Secondary Outcomes (2)

  • Colloid osmotic pressure

    6 hours

  • Fluid recruitment from tissues

    6 hours

Study Arms (2)

Rapid - Slow

EXPERIMENTAL

Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (30 minutes), second time slow (120 minutes). Albumin solution

Drug: Albumin solution

Slow - Rapid

EXPERIMENTAL

Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (120 minutes), second time slow (30 minutes). Albumin solution

Drug: Albumin solution

Interventions

Albumin solutionDRUG

Infusion rate and effects

Rapid - SlowSlow - Rapid

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy, without allergies and with the age 18 years or above

You may not qualify if:

  • Heart failure
  • Signs of kidney injury/failure
  • Severe allergies
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, University Hospital

Linköping, Sweden

Location

Study Officials

  • Joachim Zdolsek, MD, PhD,Assoc prof

    University Hospital, Linkoeping

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assoc prof, consultant

Study Record Dates

First Submitted

February 24, 2018

First Posted

March 5, 2018

Study Start

February 24, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations

SE(1)