Trial · NCT03085758

Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

NCT03085758, Phase 2, Completed, Adrenomed AG; results first posted 2021-03-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB. Trials, record NCT03085758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03085758

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Trial

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

Title: Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB
NCT number: NCT03085758
Status: Completed
Phases: Phase 2
Enrollment: 301 participants, actual
Lead sponsor: Adrenomed AG
Conditions: Septic Shock
Interventions: Adrecizumab, Placebo
First posted: 2017-03-21
Last updated: 2024-02-21
Results first posted: 2021-03-24

Source ClinicalTrials.gov

Registered outcomes39

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

List	Outcome	Time frame	Description
Primary	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality)	90 days	The endpoints for the primary objective is mortality evaluated over the 90 days study period.
Primary	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion)	90 days	The endpoints for the primary objective are to determine over the 90 days study period: Interruption of infusion due to intolerability of ADRECIZUMAB
Primary	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Frequency of TEAEs)	90 days	The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group.
Primary	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Mild Severity	90 days	The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with mild severity treatment emergent events.
Primary	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Moderate Severity	90 days	The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with moderate severity treatment emergent events.
Primary	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Severe Severity	90 days	The endpoints for the primary objective are to determine over the 90 days study period. Number of participants with treatment-emergent adverse events per treatment group with severe severity treatment emergent events.
Secondary	Efficacy to be Determined by Sepsis Support Index (SSI)	14 days	The primary efficacy endpoint of this study is the Sepsis Support Index (SSI) defined as: days with organ support or dead within 14 day follow up More precisely: In the time frame of 14 day follow-up, each day on support with vasopressor, and/or mechanical ventilation, and/or renal dysfunction (defined as renal SOFA = 4), or not alive, is counted as 1. The sum over the follow up period is defined as SSI. Minimum value possible is 0, maximum value is 14. A higher score means a worse outcome.
Secondary	Sepsis Support Index (SSI)	28 days	Sepsis Support Index (SSI) at 28 day follow-up Minimum value possible is 0, maximum value is 14. A higher score means a worse outcome.
Secondary	Penalized Sepsis Support Index (pSSI) at 14 Day Follow-up	day 14	Penalized Sepsis Support Index (pSSI) at day 14, defined similar to the SSI with the exception that patients that die get penalized by assigning the maximum value, i.e. the pSSI is set to 14 or 28, respectively. Minimum value possible is 0, maximum value is 14. A higher score means a worse outcome.
Secondary	Persistent Organ Dysfunction or Death at 14 and 28 Day Follow-up	day 14 and day 28	Persistent organ dysfunction or death at 14 and 28 day follow-up. Count of participants with either persistent organ dysfunction or death at Day 14 and Day 28. Persistent Organ Dysfunction is defined as the persistence of organ dysfunction requiring supportive technologies during the convalescent phase of critical illness and it is present when a patient has an ongoing requirement for vasopressors, dialysis, or mechanical ventilation at the outcome assessments time points, as defined by Heyland et al.; Persistent organ dysfunction plus death: a novel,composite outcome measure for critical care trials. Critical Care 2011, 15.

1 to 10 of 39Source ClinicalTrials.gov

See all 39 registered outcomes

Outcomes39

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality)	90 days	Full Analysis Set	days	MEAN
PRIMARY	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion)	90 days	Safety Analysis Set	Interruptions	NUMBER
PRIMARY	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Frequency of TEAEs)	90 days	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Mild Severity	90 days	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Moderate Severity	90 days	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Severe Severity	90 days	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy to be Determined by Sepsis Support Index (SSI)	14 days	Full Analysis Set	score on a scale	MEAN
SECONDARY	Sepsis Support Index (SSI)	28 days	Full Analysis Set	score on a scale	MEAN
SECONDARY	Penalized Sepsis Support Index (pSSI) at 14 Day Follow-up	day 14	Full Analysis Set	score on a scale	MEAN
SECONDARY	Persistent Organ Dysfunction or Death at 14 and 28 Day Follow-up	day 14 and day 28	Full Analysis Set	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 39Source ClinicalTrials.gov

See all 39 outcomes

Results by group367

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

Outcome	Group	Value	Spread	Units
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality)	Treatment Arm A	63.1453	Standard Error 4.0940	days
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality)	Treatment Arm B	63.1578	Standard Error 3.5967	days
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality)	Adrecizumab Overall	64.5744	Standard Error 2.7582	days
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality)	Control Group	63.9809	Standard Error 2.9466	days
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion)	Treatment Arm A	0		Interruptions
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion)	Treatment Arm B	1		Interruptions
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion)	Adrecizumab Overall	1		Interruptions
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion)	Control Group	0		Interruptions
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Frequency of TEAEs)	Treatment Arm A	68		Participants
Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Frequency of TEAEs)	Treatment Arm B	74		Participants

1 to 10 of 367Source ClinicalTrials.gov

See all 367 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment Arm A	72
Overall Study	STARTED	Treatment Arm B	77
Overall Study	STARTED	Control Group	152
Overall Study	COMPLETED	Treatment Arm A	43
Overall Study	COMPLETED	Treatment Arm B	49
Overall Study	COMPLETED	Control Group	96
Overall Study	NOT COMPLETED	Treatment Arm A	29
Overall Study	NOT COMPLETED	Treatment Arm B	28
Overall Study	NOT COMPLETED	Control Group	56

Source ClinicalTrials.gov

Adverse events516

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	Events
other	Hypokalaemia	Metabolism and nutrition disorders	Treatment Arm A	11	72	13
other	Hypokalaemia	Metabolism and nutrition disorders	Treatment Arm B	10	77
other	Hypokalaemia	Metabolism and nutrition disorders	Control Group	24	152
other	Hyperglycaemia	Metabolism and nutrition disorders	Treatment Arm A	11	72	12
other	Hyperglycaemia	Metabolism and nutrition disorders	Treatment Arm B	14	77
other	Hyperglycaemia	Metabolism and nutrition disorders	Control Group	12	152
other	Hypernatraemia	Metabolism and nutrition disorders	Treatment Arm A	5	72
other	Hypernatraemia	Metabolism and nutrition disorders	Treatment Arm B	12	77
other	Hypernatraemia	Metabolism and nutrition disorders	Control Group	13	152
other	Hypophosphataemia	Metabolism and nutrition disorders	Treatment Arm A	6	72

1 to 10 of 516Source ClinicalTrials.gov

See all 516 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment Arm A	26	72
Total, all-cause mortality	Treatment Arm B	24	77
Total, all-cause mortality	Control Group	54	152
Total, other adverse events	Treatment Arm A	44	72
Total, other adverse events	Treatment Arm B	68	77
Total, other adverse events	Control Group	84	152
Total, serious adverse events	Treatment Arm A	46	72
Total, serious adverse events	Treatment Arm B	42	77
Total, serious adverse events	Control Group	96	152

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30782906	DERIVED	PubMed
34605947	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 comparisons0

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

None in this release.

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/NCT03085758

GET https://conductscience.org/api/trials/v1/NCT03085758/registered?page=2

API reference For AI assistants