Trial Outcomes & Findings for IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium. (NCT NCT00091507)
NCT ID: NCT00091507
Last Updated: 2016-03-02
Results Overview
Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
911 participants
Primary outcome timeframe
24 hours
Results posted on
2016-03-02
Participant Flow
Participant milestones
| Measure |
GIK --
GIK = glucose-insulin-potassium
|
Placebo
Dextrose 5%
|
|---|---|---|
|
Overall Study
STARTED
|
432
|
479
|
|
Overall Study
COMPLETED
|
411
|
460
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
Baseline characteristics by cohort
| Measure |
GIK --
n=432 Participants
GIK = glucose-insulin-potassium
|
Placebo
n=479 Participants
Dextrose 5%
|
Total
n=911 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 13.9 • n=39 Participants
|
63.3 years
STANDARD_DEVIATION 14.1 • n=41 Participants
|
63.6 years
STANDARD_DEVIATION 14.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=39 Participants
|
146 Participants
n=41 Participants
|
265 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
313 Participants
n=39 Participants
|
333 Participants
n=41 Participants
|
646 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
432 participants
n=39 Participants
|
479 participants
n=41 Participants
|
911 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOutcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.
Outcome measures
| Measure |
GIK --
n=411 Participants
GIK = glucose-insulin-potassium
|
Placebo
n=460 Participants
Dextrose 5%
|
|---|---|---|
|
Progression of Acute Coronary Syndrome to Myocardial Infarction
|
200 participants
|
242 participants
|
SECONDARY outcome
Timeframe: 1 to 18 hours (From prehospital setting through hospitalization.)Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.
Outcome measures
| Measure |
GIK --
n=411 Participants
GIK = glucose-insulin-potassium
|
Placebo
n=460 Participants
Dextrose 5%
|
|---|---|---|
|
Cardiac Arrest
|
15 participants
|
29 participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)
Outcome measures
| Measure |
GIK --
n=411 Participants
GIK = glucose-insulin-potassium
|
Placebo
n=460 Participants
Dextrose 5%
|
|---|---|---|
|
Heart Failure or Death
|
23 participants
|
35 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 30 day mortality.
Outcome for all participants (mortality at 30 days).
Outcome measures
| Measure |
GIK --
n=411 Participants
GIK = glucose-insulin-potassium
|
Placebo
n=460 Participants
Dextrose 5%
|
|---|---|---|
|
Mortality
|
18 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Prehospital setting through hospitalizationOutcome for all participants (composite of cardiac arrest or acute mortality)
Outcome measures
| Measure |
GIK --
n=411 Participants
GIK = glucose-insulin-potassium
|
Placebo
n=460 Participants
Dextrose 5%
|
|---|---|---|
|
Cardiac Arrest or Acute Mortality
|
18 participants
|
40 participants
|
Adverse Events
GIK --
Serious events: 28 serious events
Other events: 295 other events
Deaths: 0 deaths
Placebo
Serious events: 41 serious events
Other events: 199 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GIK --
n=411 participants at risk
GIK = glucose-insulin-potassium
|
Placebo
n=460 participants at risk
Dextrose 5%
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.24%
1/411 • Number of events 1
|
0.00%
0/460
|
|
Cardiac disorders
Atrial fibrillation
|
0.24%
1/411 • Number of events 1
|
0.43%
2/460 • Number of events 2
|
|
Cardiac disorders
Cardiac arrest
|
0.97%
4/411 • Number of events 4
|
2.8%
13/460 • Number of events 13
|
|
Cardiac disorders
Cardiac failure
|
0.24%
1/411 • Number of events 1
|
0.00%
0/460
|
|
Cardiac disorders
Cardiogenic shock
|
0.97%
4/411 • Number of events 4
|
2.2%
10/460 • Number of events 10
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
1.5%
6/411 • Number of events 6
|
1.3%
6/460 • Number of events 6
|
|
Cardiac disorders
Ventricular tachycardia
|
0.97%
4/411 • Number of events 4
|
1.3%
6/460 • Number of events 6
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.24%
1/411 • Number of events 1
|
0.00%
0/460
|
|
General disorders
Multi-organ failure
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkaelemia
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
0.24%
1/411 • Number of events 1
|
0.00%
0/460
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.49%
2/411 • Number of events 2
|
0.22%
1/460 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.24%
1/411 • Number of events 1
|
0.00%
0/460
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.24%
1/411 • Number of events 1
|
0.00%
0/460
|
|
Vascular disorders
Catheter site haemorrhage
|
0.49%
2/411 • Number of events 2
|
0.00%
0/460
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.24%
1/411 • Number of events 1
|
0.22%
1/460 • Number of events 1
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/411
|
0.22%
1/460 • Number of events 1
|
|
Vascular disorders
Pulmonary embolism
|
0.49%
2/411 • Number of events 2
|
0.00%
0/460
|
Other adverse events
| Measure |
GIK --
n=411 participants at risk
GIK = glucose-insulin-potassium
|
Placebo
n=460 participants at risk
Dextrose 5%
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
4.6%
19/411 • Number of events 19
|
3.7%
17/460 • Number of events 17
|
|
Cardiac disorders
Ventricular extrasystoles
|
6.1%
25/411 • Number of events 25
|
7.0%
32/460 • Number of events 32
|
|
Cardiac disorders
Ventricular tachycardia
|
5.8%
24/411 • Number of events 24
|
6.5%
30/460 • Number of events 30
|
|
Endocrine disorders
Hyperglycaemia
|
35.8%
147/411 • Number of events 147
|
14.3%
66/460 • Number of events 66
|
|
Endocrine disorders
Hypoglycaemia
|
8.5%
35/411 • Number of events 35
|
0.65%
3/460 • Number of events 3
|
|
General disorders
Injection site reaction
|
14.1%
58/411 • Number of events 58
|
2.2%
10/460 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.6%
27/411 • Number of events 27
|
2.8%
13/460 • Number of events 13
|
|
Vascular disorders
Hypotension
|
7.1%
29/411 • Number of events 29
|
6.1%
28/460 • Number of events 28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place