Trial Outcomes & Findings for Gelatin in ICU and Sepsis (NCT NCT02715466)
NCT ID: NCT02715466
Last Updated: 2025-08-19
Results Overview
Time from first administration of IMP to first achievement of confirmed hemodynamic stability
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
167 participants
Primary outcome timeframe
48 hours after treatment start
Results posted on
2025-08-19
Participant Flow
Participant milestones
| Measure |
Gelatine
Balanced gelatine solution
Balanced gelatine solution: Gelaspan combined with Sterofundin ISO
Balanced electrolyte solution: Sterofundin ISO
|
Electrolyte
Balanced electrolyte solution
Balanced electrolyte solution: Sterofundin ISO
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
84
|
|
Overall Study
COMPLETED
|
83
|
84
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gelatin in ICU and Sepsis
Baseline characteristics by cohort
| Measure |
Gelatine
n=83 Participants
Balanced gelatine solution
Balanced gelatine solution: Gelaspan combined with Sterofundin ISO
Balanced electrolyte solution: Sterofundin ISO
|
Electrolyte
n=84 Participants
Balanced electrolyte solution
Balanced electrolyte solution: Sterofundin ISO
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 14.20 • n=93 Participants
|
65.9 years
STANDARD_DEVIATION 14.14 • n=4 Participants
|
65.6 years
STANDARD_DEVIATION 14.13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
165 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Region of Enrollment
Czechia
|
10 participants
n=93 Participants
|
9 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Region of Enrollment
France
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
59 participants
n=93 Participants
|
61 participants
n=4 Participants
|
120 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=93 Participants
|
6 participants
n=4 Participants
|
14 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 48 hours after treatment startPopulation: Intent-to-treat set
Time from first administration of IMP to first achievement of confirmed hemodynamic stability
Outcome measures
| Measure |
Gelatine
n=77 Participants
Balanced gelatine solution
Balanced gelatine solution: Gelaspan combined with Sterofundin ISO
Balanced electrolyte solution: Sterofundin ISO
|
Electrolyte
n=74 Participants
Balanced electrolyte solution
Balanced electrolyte solution: Sterofundin ISO
|
|---|---|---|
|
Time Until First/Initial Hemodynamic Stabilization
|
4.7 hours
Standard Deviation 5.88
|
5.8 hours
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: Intensive care unit (ICU) discharge or day 28Population: Intent-to-treat set
Length of stay (LOS) in the intensive care unit (ICU)= Date of ICU discharge - date of ICU admission + 1
Outcome measures
| Measure |
Gelatine
n=55 Participants
Balanced gelatine solution
Balanced gelatine solution: Gelaspan combined with Sterofundin ISO
Balanced electrolyte solution: Sterofundin ISO
|
Electrolyte
n=53 Participants
Balanced electrolyte solution
Balanced electrolyte solution: Sterofundin ISO
|
|---|---|---|
|
Length of Stay (LOS) in the Intensive Care Unit (ICU)
|
11.9 days
Standard Deviation 9.32
|
12.8 days
Standard Deviation 10.98
|
Adverse Events
Gelatine
Serious events: 30 serious events
Other events: 55 other events
Deaths: 11 deaths
Electrolyte
Serious events: 34 serious events
Other events: 54 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Gelatine
n=83 participants at risk
Balanced gelatine solution
Balanced gelatine solution: Gelaspan combined with Sterofundin ISO
Balanced electrolyte solution: Sterofundin ISO
|
Electrolyte
n=84 participants at risk
Balanced electrolyte solution
Balanced electrolyte solution: Sterofundin ISO
|
|---|---|---|
|
Infections and infestations
Septic shock
|
7.2%
6/83 • Number of events 6 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
10.7%
9/84 • Number of events 9 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
2.4%
2/84 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Infections and infestations
Pneumonia
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Infections and infestations
Abscess neck
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Infections and infestations
Necrotising fasciitis
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Infections and infestations
Pulmonary sepsis
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
General disorders
Multiple organ dysfunction syndrome
|
8.4%
7/83 • Number of events 7 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
14.3%
12/84 • Number of events 12 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 5 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
3.6%
3/84 • Number of events 3 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Cardiac failure
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Right ventricular failure
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Tachyarrhythmia
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
3.6%
3/83 • Number of events 3 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
3.6%
3/84 • Number of events 3 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Injury, poisoning and procedural complications
Suture rupture
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Hypotension
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
2.4%
2/84 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Haemorrhage
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Shock haemorrhagic
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Haematoma
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Hypovolaemic shock
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Vascular disorders
Ischaemia
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Brain injury
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
2.4%
2/84 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Cerebral haematoma
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Generalised tonic-clonic
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Paraplegia
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Seizure
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Somnolence
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Spinal cord ischaemia
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Hepatobiliary disorders
Hepatic failure
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Hepatobiliary disorders
Hepatic infarction
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Surgical and medical procedures
Explorative laparotomy
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Surgical and medical procedures
Leg amputation
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Product Issues
Device occlusion
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
0.00%
0/84 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
Other adverse events
| Measure |
Gelatine
n=83 participants at risk
Balanced gelatine solution
Balanced gelatine solution: Gelaspan combined with Sterofundin ISO
Balanced electrolyte solution: Sterofundin ISO
|
Electrolyte
n=84 participants at risk
Balanced electrolyte solution
Balanced electrolyte solution: Sterofundin ISO
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.8%
9/83 • Number of events 9 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
6.0%
5/84 • Number of events 5 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/83 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.6%
3/83 • Number of events 3 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
6.0%
5/84 • Number of events 5 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.8%
4/83 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
18.1%
15/83 • Number of events 15 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
17.9%
15/84 • Number of events 16 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
4.8%
4/83 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
11.9%
10/84 • Number of events 10 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.2%
6/83 • Number of events 6 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Atrial fibrillation
|
10.8%
9/83 • Number of events 9 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
11.9%
10/84 • Number of events 12 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Cardiac disorders
Bradycardia
|
4.8%
4/83 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
2.4%
2/84 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Infections and infestations
Pneumonia
|
2.4%
2/83 • Number of events 2 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Infections and infestations
Septic shock
|
4.8%
4/83 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
1.2%
1/84 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.4%
7/83 • Number of events 7 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
7.1%
6/84 • Number of events 6 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Investigations
Haemoglobin decreased
|
3.6%
3/83 • Number of events 3 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 4 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
12.0%
10/83 • Number of events 12 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
7.1%
6/84 • Number of events 6 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
1.2%
1/83 • Number of events 1 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
4.8%
4/84 • Number of events 7 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
|
Nervous system disorders
Delirium
|
3.6%
3/83 • Number of events 3 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
6.0%
5/84 • Number of events 5 • From randomization until ICU discharge or day 28- whatever occurs first (max. 28 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60