Clinical TrialID 6095

Anticholium® Per Se

NCT03013322

Shock, Septic|Sepsis|Perioperative Period

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Record Fields

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Clinical Trial Id
6095
Evidence Id
6095
Core Evidence Id
6095
Source Clinical Trial Id
6077
Herb2 Clinical Trial Id
HBCT006077
Nct Id
NCT03013322
Title
Anticholium® Per Se
Status
Completed
Phase
Study Result
No
Study Condition
Shock, Septic|Sepsis|Perioperative Period
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Physostigmine|DRUG: Isotonic Saline
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
20
Outcome Measure
mean Sequential Organ Failure Assessment (SOFA) score, The mean SOFA score (at least two individual values) during treatment and subsequent intensive care of up to 14 days is used as surrogate outcome in critically ill patients with perioperative sepsis and septic shock due to intra-abdominal infection., up to 14 d, assessed 2 h±30 min, 24±2 h, 48±2 h, 72±2 h, 96±2 h, 120±2 h, 6 d±4 h, 7 d±4 h, 8 d±8 h, 9 d±8 h, 10 d±8 h, 11 d±8 h, 12 d±8 h, 13 d±8 h, 14 d±8 h after continuous infusion is commenced
Sponsor Collaborator
University Hospital Heidelberg
Funded By
OTHER
Location
University Hospital Heidelberg, Heidelberg, Baden-Württemberg, 69120, Germany
Other Id
D.10060224
Start Date
2015-01-28
Primary Completion Date
2017-02-18
Completion Date
2017-02-18
First Posted
2017-01-06
Results First Posted
Last Update Posted
2018-01-29
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03013322
Title Cn
Title En
Anticholium® Per Se
Bilingual Status
semi_complete