Trial · NCT03869385

Albumin Replacement Therapy in Septic Shock

NCT03869385, Phase 3, Terminated, Jena University Hospital; results first posted 2024-10-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Albumin Replacement Therapy in Septic Shock. Trials, record NCT03869385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03869385

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Albumin Replacement Therapy in Septic Shock
NCT number: NCT03869385
Status: Terminated
Phases: Phase 3
Enrollment: 440 participants, actual
Lead sponsor: Jena University Hospital
Conditions: Septic Shock
Interventions: Albutein® 200 g/L or Plasbumin® 20
First posted: 2019-03-11
Last updated: 2024-10-28
Other registries' IDs: eudract:2018-001874-89
Results first posted: 2024-10-28

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	90-day All Cause Mortality	90 days	Mortality within 90 days after randomisation
Secondary	28-day Mortality	28 days	Mortality within 28 days after randomisation
Secondary	60-day Mortality	60 days	Mortality within 60 days after randomisation
Secondary	Organ Failure	28 days	Organ failure defined as increase in the daily recorded Sequential organ Failure Assessement (SOFA) subscores; cardiovascular, respiratory, hematologic, hepatic, renal, neurologic (range 0-4 points each) from a value \<2 to a value ≥ 2
Secondary	Sequential Organ Failure Assessement (SOFA) Score	28 days	The overall degree of organ dysfunction/failure assessed daily by the total Sequential Organ Failure Score (SOFA score: range 0-24 points), with higher scores indicating higher degree of overall organ dysfunction/failure).
Secondary	ICU Length of Stay	90 days	Intensive Care unit stay of first hospitalization after randomisation within 90 days
Secondary	Hospital Length of Stay	90 days	Hospital stay of first hospitalization after randomisation within 90 days
Secondary	Ventilation-free Days	28 days	Ventilation-free days within 28 days after randomisation
Secondary	Vasopressor-free Days	28 days	Vasopressor-free days within 28 days after randomisation
Secondary	Total Amount of Fluid of Fluid Administration and Total Fluid Balance in the ICU.	28 days	Total amount of fluid of fluid administration and total fluid balance in the ICU within 28 days after randomisation

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	90-day All Cause Mortality	90 days	Informed consents were not possible to obtain within 72 hours after randomization in 14 patients, 4 patients were lost to follow up, 2 patients withdrew the informed consent, and the study was terminated in one patient due to investigator decision. Therefore, the primary outcome parameter was available for analysis in 210 patients in the albumin and 209 patients in the control groups	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	28-day Mortality	28 days	At 28 days after randomization, informed consent was not possible to be obtained within 72 hours of randomization in 14 patients, 2 patients withdrew consent, and the study was terminated in one patient due to investigator decision. Therefore, 28-days mortality were available in 213 vs. 210 patients in the albumin vs. control group, respectively	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	60-day Mortality	60 days	At 60 days after randomization, informed consent was not possible to be obtained within 72 hours of randomization in 14 patients, 2 patients withdrew consent, 2 patients were lost to follow-up, and the study was terminated in one patient due to investigator decision. Therefore, 60-days mortality were available in 211 vs. 210 patients in the albumin vs. control group, respectively	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Organ Failure	28 days		participants	NUMBER
SECONDARY	Sequential Organ Failure Assessement (SOFA) Score	28 days		Points	MEAN
SECONDARY	ICU Length of Stay	90 days		Days	MEDIAN
SECONDARY	Hospital Length of Stay	90 days		Days	MEDIAN
SECONDARY	Ventilation-free Days	28 days		Days	MEDIAN
SECONDARY	Vasopressor-free Days	28 days		Days	MEDIAN
SECONDARY	Total Amount of Fluid of Fluid Administration and Total Fluid Balance in the ICU.	28 days		ml/day	MEDIAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
90-day All Cause Mortality	Albumin Group		91	Participants
90-day All Cause Mortality	Control Group Without Albumin:		96	Participants
28-day Mortality	Albumin Group		66	Participants
28-day Mortality	Control Group Without Albumin:		80	Participants
60-day Mortality	Albumin Group		82	Participants
60-day Mortality	Control Group Without Albumin:		95	Participants
Organ Failure	Albumin Group	1 organ failure	68	participants
Organ Failure	Control Group Without Albumin:	1 organ failure	52	participants
Organ Failure	Albumin Group	2 organ failures	19	participants
Organ Failure	Control Group Without Albumin:	2 organ failures	14	participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Albumin Group	222
Overall Study	STARTED	Control Group Without Albumin:	218
Overall Study	COMPLETED	Albumin Group	222
Overall Study	COMPLETED	Control Group Without Albumin:	218
Overall Study	NOT COMPLETED	Albumin Group	0
Overall Study	NOT COMPLETED	Control Group Without Albumin:	0

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Sepsis related, Cardiovascular events	Vascular disorders	Albumin Group	183	222
other	Sepsis related, Cardiovascular events	Vascular disorders	Control Group Without Albumin:	176	218
serious	Hypervolemia	Cardiac disorders	Albumin Group	3	222
serious	Hypervolemia	Cardiac disorders	Control Group Without Albumin:	2	218

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Albumin Group	91	222
Total, all-cause mortality	Control Group Without Albumin:	96	218
Total, other adverse events	Albumin Group	183	222
Total, other adverse events	Control Group Without Albumin:	176	218
Total, serious adverse events	Albumin Group	3	222
Total, serious adverse events	Control Group Without Albumin:	2	218

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33287911	DERIVED	PubMed
41712212	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Albumin Group vs Control Group Without Albumin:: 60-day Mortality	Trial comparisons
Albumin Group vs Control Group Without Albumin:: 90-day All Cause Mortality	Trial comparisons
Albumin Group vs Control Group Without Albumin:: deaths from any cause	Trial comparisons
Albumin Group vs Control Group Without Albumin:: 28-day Mortality	Trial comparisons
Albumin Group vs Control Group Without Albumin:: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03869385

GET https://conductscience.org/api/trials/v1/NCT03869385/results?page=2

API reference For AI assistants