Trial Outcomes & Findings for Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial (NCT NCT04963569)

NCT ID: NCT04963569

Last Updated: 2025-04-15

Results Overview

Exploratory analysis to map mechanistic inflammatory response over time: 0, 12 and 24 hours. As the analysis is exploratory, there is no defined limit to cell types or cytokines measured. Cytokines measured: tumour necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), granulocyte-macrophage colony-stimulating factor (GM-CSF), C-X-C motif chemokine ligand 10 (CXCL10), interleukin 5 (IL-5), interferon alpha 2 (IFN-a2), interleukin 4 (IL-4), C-C motif chemokine ligand 3 (CCL3), interleukin 10 (IL-10), interleukin 12p70 (IL-12p70), C-C motif chemokine ligand 20 (CCL20), interferon gamma (IFN-gamma), C-X-C motif chemokine ligand 8 (CXCL8), and C-C motif chemokine 4(CCL4). This outcome measure describes the number of participants who were eligible for inclusion in the exploratory analysis described above and in later outcomes. Units: number of participants eligible for inclusion in comparison.

• Recruitment status: COMPLETED
• Target enrollment: 26 participants
• Primary outcome timeframe: At presentation, 12 and 24 hours.
• Results posted on: 2025-04-15

Participant Flow

Participant milestones

Measure	Albumin Participants enrolled in the ABC Sepsis trial who have been randomised to 5% Human Albumin Solution as the sole resuscitative fluid in the first 6 hours.	Balanced Crystalloid Participants enrolled in the ABC Sepsis trial who have been randomised to Balanced Crystalloid as the sole resuscitative fluid in the first 6 hours.
Overall Study STARTED	14	12
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Albumin n=14 Participants Participants enrolled in the ABC Sepsis trial who have been randomised to 5% Human Albumin Solution as the sole resuscitative fluid in the first 6 hours.	Balanced Crystalloid n=12 Participants Participants enrolled in the ABC Sepsis trial who have been randomised to Balanced Crystalloid as the sole resuscitative fluid in the first 6 hours.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=26 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=14 Participants	2 Participants n=12 Participants	6 Participants n=26 Participants
Age, Categorical >=65 years	10 Participants n=14 Participants	10 Participants n=12 Participants	20 Participants n=26 Participants
Sex: Female, Male Female	7 Participants n=14 Participants	7 Participants n=12 Participants	14 Participants n=26 Participants
Sex: Female, Male Male	7 Participants n=14 Participants	5 Participants n=12 Participants	12 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	14 participants n=14 Participants	12 participants n=12 Participants	26 participants n=26 Participants

PRIMARY outcome

Timeframe: At presentation, 12 and 24 hours.

Population: Non-numerical outcome; all participants included in analysis.

Exploratory analysis to map mechanistic inflammatory response over time: 0, 12 and 24 hours. As the analysis is exploratory, there is no defined limit to cell types or cytokines measured.

Cytokines measured: tumour necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), granulocyte-macrophage colony-stimulating factor (GM-CSF), C-X-C motif chemokine ligand 10 (CXCL10), interleukin 5 (IL-5), interferon alpha 2 (IFN-a2), interleukin 4 (IL-4), C-C motif chemokine ligand 3 (CCL3), interleukin 10 (IL-10), interleukin 12p70 (IL-12p70), C-C motif chemokine ligand 20 (CCL20), interferon gamma (IFN-gamma), C-X-C motif chemokine ligand 8 (CXCL8), and C-C motif chemokine 4(CCL4).

This outcome measure describes the number of participants who were eligible for inclusion in the exploratory analysis described above and in later outcomes.

Units: number of participants eligible for inclusion in comparison.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis.	14 participants	12 participants

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at Presentation	18.3 pg/mL Standard Deviation 18.9	8.7 pg/mL Standard Deviation 14.9

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 12 Hours	15.4 pg/mL Standard Deviation 14.0	6.6 pg/mL Standard Deviation 6.8

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 24 Hours	16.5 pg/mL Standard Deviation 14.2	7.3 pg/mL Standard Deviation 10.3

PRIMARY outcome

Timeframe: 0 hours

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at Presentation	9.9 pg/mL Standard Deviation 10.6	4.5 pg/mL Standard Deviation 7.4

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 12 Hours	7.2 pg/mL Standard Deviation 8.2	2.8 pg/mL Standard Deviation 4.2

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 24 Hours	7.7 pg/mL Standard Deviation 9.5	3.1 pg/mL Standard Deviation 4.5

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 0 Hours	2017.9 pg/mL Standard Deviation 5436.7	2513.3 pg/mL Standard Deviation 6423.3

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 12 Hours	492.0 pg/mL Standard Deviation 1557.3	305.6 pg/mL Standard Deviation 764.6

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 24 Hours	119.0 pg/mL Standard Deviation 247.0	52.3 pg/mL Standard Deviation 72.7

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 0 Hours	453.1 pg/mL Standard Deviation 496.0	1073.3 pg/mL Standard Deviation 2240.0

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 12 Hours	816.6 pg/mL Standard Deviation 1243.1	846.1 pg/mL Standard Deviation 1534.6

PRIMARY outcome

Timeframe: 24 hours from presentation.

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 24 Hours	450.7 pg/mL Standard Deviation 626.2	324.4 pg/mL Standard Deviation 369.3

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 0 Hours	5.8 pg/mL Standard Deviation 5.6	15.6 pg/mL Standard Deviation 44.8

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 12 Hours	4.9 pg/mL Standard Deviation 4.4	18.4 pg/mL Standard Deviation 55.5

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 24 Hours	5.0 pg/mL Standard Deviation 4.6	2.4 pg/mL Standard Deviation 3.9

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 0 Hours	16.6 pg/mL Standard Deviation 27.7	5.6 pg/mL Standard Deviation 5.0

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 12 Hours	12.3 pg/mL Standard Deviation 18.5	4.2 pg/mL Standard Deviation 2.6

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 24 Hours	11.0 pg/mL Standard Deviation 9.9	4.0 pg/mL Standard Deviation 3.5

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 0 Hours	19.5 pg/mL Standard Deviation 22.1	9.0 pg/mL Standard Deviation 12.0

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 12 Hours	14.6 pg/mL Standard Deviation 15.2	5.5 pg/mL Standard Deviation 5.0

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 24 Hours	14.4 pg/mL Standard Deviation 21.3	7.1 pg/mL Standard Deviation 10.9

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 0 Hours	127.2 pg/mL Standard Deviation 176.9	55.5 pg/mL Standard Deviation 55.4

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours from presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 12 Hours	95.7 pg/mL Standard Deviation 128.7	48.5 pg/mL Standard Deviation 63.5

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 24 Hours	98.0 pg/mL Standard Deviation 96.0	35.1 pg/mL Standard Deviation 35.1

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 0 Hours	748.1 pg/mL Standard Deviation 2170.0	715.3 pg/mL Standard Deviation 2130.6

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 12 Hours	620.8 pg/mL Standard Deviation 2275.7	47.2 pg/mL Standard Deviation 100.2

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 24 Hours	362.8 pg/mL Standard Deviation 1326.1	5.3 pg/mL Standard Deviation 4.6

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 0 Hours	24.2 pg/mL Standard Deviation 59.6	6.4 pg/mL Standard Deviation 8.5

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 12 Hours	34.8 pg/mL Standard Deviation 108.5	3.9 pg/mL Standard Deviation 4.4

PRIMARY outcome

Timeframe: 24 hours from baseline

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 24 Hours	11.4 pg/mL Standard Deviation 19.5	3.0 pg/mL Standard Deviation 3.1

PRIMARY outcome

Timeframe: 0 hours from baseline

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 0 Hours	1792.5 pg/mL Standard Deviation 2390.7	708.2 pg/mL Standard Deviation 526.3

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 12 Hours	555.4 pg/mL Standard Deviation 504.1	659.3 pg/mL Standard Deviation 942.2

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 24 Hours	314.1 pg/mL Standard Deviation 228.3	276.7 pg/mL Standard Deviation 215.1

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at Presentation	172.1 pg/mL Standard Deviation 194.7	31.2 pg/mL Standard Deviation 29.4

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 0 Hours	114.3 pg/mL Standard Deviation 113.2	29.8 pg/mL Standard Deviation 23.2

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 24 Hours	99.7 pg/mL Standard Deviation 102.7	27.0 pg/mL Standard Deviation 39.5

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 0 Hours	203.3 pg/mL Standard Deviation 320.3	149.5 pg/mL Standard Deviation 286.6

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 12 Hours	114.4 pg/mL Standard Deviation 189.3	70.9 pg/mL Standard Deviation 94.4

PRIMARY outcome

Timeframe: 24 hours from baseline

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 24 Hours	88.3 pg/mL Standard Deviation 95.8	39.4 pg/mL Standard Deviation 39.7

PRIMARY outcome

Timeframe: 0 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 0 Hours	11.0 pg/mL Standard Deviation 7.3	19.6 pg/mL Standard Deviation 30.2

PRIMARY outcome

Timeframe: 12 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 12 Hours	6.8 pg/mL Standard Deviation 3.8	13.6 pg/mL Standard Deviation 22.4

PRIMARY outcome

Timeframe: 24 hours from presentation

Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.

Outcome measures

Measure	Albumin n=14 Participants 5% HAS	Crystalloid n=12 Participants Balanced crystalloid
Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 24 Hours	6.1 pg/mL Standard Deviation 3.7	9.8 pg/mL Standard Deviation 11.8

Adverse Events

Albumin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Balanced Crystalloid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr John (Jack) Cafferkey

NHS Lothian/University of Edinburgh

Phone: 0

Email: j.cafferkey@ed.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place