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Trial registered on ANZCTR


Registration number
ACTRN12616001505493
Ethics application status
Approved
Date submitted
13/10/2016
Date registered
31/10/2016
Date last updated
17/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Mass balance of albumin in sepsis
Scientific title
An observational pilot study of albumin kinetics as assessed by mass balance in patients with severe sepsis/septic shock
Secondary ID [1] 290327 0
Nil known
Universal Trial Number (UTN)
U1111-1188-1309
Trial acronym
Albumin 6B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe sepsis / septic shock 300590 0
Condition category
Condition code
Infection 300443 300443 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with severe sepsis/septic shock, admitted to the ICU, will be studied during 24 hrs. Blood will be sampled repeatedly (at arrival to ICU, at 1, 2, 4, 8-12 and 24 hrs after the first sample) for assessment of albumin, markers of endothelial injury and markers of inflammation. Samples will also be taken from any patient excretions and from intravenously infused blood products. Baseline plasma volume will be calculated by anthropometry. The sum of all blood samples will not exceed 20 ml.
Intervention code [1] 296137 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299877 0
cumulative albumin shift, i.e. loss of albumin from the blood not explained by bleeding or other external losses. By repeated measurements of blood hemoglobin and plasma albumin, combined with meticulous assessment of gained and lost albumin and hemoglobin, it is possible to compare losses of albumin with losses of hemoglobin. In a previous study in surgical patients, albumin was lost to a higher amount, i.e. the cumulative albumin shift, presumably to the extracellular space.
Timepoint [1] 299877 0
24 hrs after ICU admission (compared to baseline at ICU admission, when the cumulative albumin shift per definition is zero)
Secondary outcome [1] 328367 0
Plasma albumin by nephelometry
Timepoint [1] 328367 0
At admission to ICU, after approximately 1, 2, 4, 8-12, and 24 hrs
Secondary outcome [2] 328368 0
Time course of markers of endothelial injury (such as heparan sulphate, syndecan 1, hyalorone) measured by ELISA in plasma samples
Timepoint [2] 328368 0
At ICU admission, and after approximately 2, 4, 8-12 and 24 hrs
Secondary outcome [3] 328369 0
Time course of markers of inflammation (such as IL6, IL8, IL10) measured by ELISA in plasma samples
Timepoint [3] 328369 0
At ICU admission, and after approximately 2, 4, 8-12 and 24 hrs
Secondary outcome [4] 328370 0
Plasma volume dilution, by repeated measures of B-Hb and P-alb and gains and losses of fluids
Timepoint [4] 328370 0
At ICU admission, and after approximately 1, 2, 4, 8-12, and 24 hrs
Secondary outcome [5] 328371 0
Body weight by scale
Timepoint [5] 328371 0
At ICU admission and after approximately 24 hrs
Secondary outcome [6] 328372 0
Fluid balance by keeping track of gains and losses. Infused fluid volumes are registered in the ICU electronic data record (both intravenous and enteral, all fluids given by pumps), urine is sampled continuously and registered hourly in the same electronic system. Other fluid losses such as bleeding or gastric retensions) are recorded at demand or at least every 8 hrs in the electronic patient record.
Timepoint [6] 328372 0
At ICU admission and after approximately 24 hrs
Secondary outcome [7] 328373 0
Composite hypothesis generating correlations between albumin kinetic parameters, markers of inflammation and endothelial injury, and indices of volume status. Albumin kinetic parameters (P-alb, plasma dilution, cumulative albumin shift) are assessed by P-alb, B-Hb and assessment of gains and losses of albumin and hemoglobin. Markers of inflammation and endothelial injury by ELISA of plasma samples. Volume status is assessed by gain and losses of fluids and by scale, respectively.
Timepoint [7] 328373 0
At ICU admission and at approximately 24 hrs.
Secondary outcome [8] 328374 0
Rate of fluid administration, by the ICU computerized record system
Timepoint [8] 328374 0
Continuously during the the first day after ICU admission.

Eligibility
Key inclusion criteria
Patients admitted to ICU for severe sepsis/septic shock
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absence of written informed consent
Death or transport to another hospital

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Normality of data will be assessed by Sharpio-Wilk’s test of normality and parametric or non-parametric analysis applied accordingly. The primary endpoint will be evaluated by t-test or Wilcoxon, as appropriate. Likewise correlations will be reported as Pearson’s correlation coefficient r or Spearman's rank correlation rs.
Demographic preoperative data such as age, height, weight, BMI, gender, routine lab, history of weight loss, diagnoses, and current medications will be presented as numbers, averages and standard deviation, or as median range as applicable.
In a previous study in patients undergoing major abdominal surgery at Karolinska University Hospital Huddinge the cumulative loss of albumin at the end of surgery was 24 +/- 17 g that was not explained by bleeding. The situation in septic ICU patients has not previously been described by mass balance of albumin to our knowledge. The Transcapillary escape rate of albumin is elevated, but if this is accompanied by a decreased return of lymph to the blood is not known. Because large body weight gain and an increased capillary leakage have been demonstrated by other techniques, it seems likely that albumin is accumulated outside the blood. If, by the present routine, the same amount is lost during the first 24 hrs as during major surgery, i.e. 24 +/- 17 g albumin, this corresponds to a effect size of 1.4 (difference divided by standard deviation). Then only n=8 patients are necessary to reach a statistical power of 90%. Because ICU patients are likely to have a larger variation, we aim at 10 evaluable patients. Furthermore, in the absence of a true baseline, it is important to take the first blood sample at the earliest possible instant.
Under "recruitment" (step 7) we specify the total number of patients to 20. Death, transfer to other hospitals or extreme outliers are possible, and we aim at 10 fully evaluable patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2017
Actual
Date of last participant enrolment
Anticipated
30/03/2018
Actual
Date of last data collection
Anticipated
31/03/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 8315 0
Sweden
State/province [1] 8315 0

Funding & Sponsors
Funding source category [1] 294706 0
Government body
Name [1] 294706 0
Supported by grants provided by the Stockholm County Council (ALF project), grant #20160054
Country [1] 294706 0
Sweden
Primary sponsor type
Individual
Name
Ake Norberg
Address
Perioperative Medicine and Intensive Care, B31
Karolinska University Hospital, Huddinge
SE-141 86 Stockholm
Country
Sweden
Secondary sponsor category [1] 293554 0
None
Name [1] 293554 0
Address [1] 293554 0
Country [1] 293554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296127 0
Regional Ethical Board in Stockholm
Ethics committee address [1] 296127 0
Ethics committee country [1] 296127 0
Sweden
Date submitted for ethics approval [1] 296127 0
24/10/2016
Approval date [1] 296127 0
16/11/2016
Ethics approval number [1] 296127 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1461 1461 0 0
/AnzctrAttachments/371651-Beslut EPN 161116.pdf (Ethics approval)

Contacts
Principal investigator
Name 69662 0
Dr Ake Norberg
Address 69662 0
Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC)
and
Department of Perioperative Medicine and Intensive Care, B31
Karolinska University Hospital, Huddinge
SE-141 86 Stockholm
Country 69662 0
Sweden
Phone 69662 0
+46 73 966 11 52
Fax 69662 0
+46 8 779 54 24
Email 69662 0
[email protected]
Contact person for public queries
Name 69663 0
Ake Norberg
Address 69663 0
Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC)and
Department of Perioperative Medicine and Intensive Care, B31
Karolinska University Hospital, Huddinge
SE-141 86 Stockholm
Country 69663 0
Sweden
Phone 69663 0
+46 73 966 11 52
Fax 69663 0
+46 8 779 54 24
Email 69663 0
[email protected]
Contact person for scientific queries
Name 69664 0
Ake Norberg
Address 69664 0
Karolinska Institutet, Department of Clinical Science, Intervention and Technology (CLINTEC)and
Department of Perioperative Medicine and Intensive Care, B31
Karolinska University Hospital, Huddinge
SE-141 86 Stockholm
Country 69664 0
Sweden
Phone 69664 0
+46 73 966 11 52
Fax 69664 0
+46 8 779 54 24
Email 69664 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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