Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock (COIITSS)
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| ClinicalTrials.gov Identifier: NCT00320099 |
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Recruitment Status :
Completed
First Posted : May 3, 2006
Last Update Posted : April 6, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Septic Shock | Drug: recombinant human insulin Drug: hydrocortisone Drug: fludrocortisone Drug: Hydrocortisone | Phase 3 |
Objectives:
Comparison, in patients with septic shock, of efficacy and safety of the combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids; and of efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone Methods
Study design :
This is a multicenter, prospective, randomised trial on parallel groups
Study treatments :
Experimental arm A:
A1=50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge.
A2=50 mg iv every 6 hours of hydrocortisone (hemisuccinate) for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge.
Control arm B:
B1:50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days.
B2:50 mg iv every 6 hours of hydrocortisone (hemisuccinate)for 7 days. Study Primary outcome : In-hospital mortality
Sample size calculation :
The expected in-hospital mortality rate in the control group is 50%. To detect an absolute reduction in in-hospital mortality rate of 12.5 %, that is 37.5% in the experimental arm versus 50% in the control arm, and considering risk alpha of 0,05 and a risk beta of 0,20, 254 patients per treatment arms are needed, for a total of 508 patients.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 508 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | February 2009 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Hydrocortisone and convention glycemic control
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Drug: hydrocortisone
50 mg as iv bolus every 6 hours for 7 days Drug: Hydrocortisone hydrocortisone 50mg q6 for 7 days |
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Experimental: 2
Hydrocortisone and fludrocortisone and conventional glucose control
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Drug: hydrocortisone
50 mg as iv bolus every 6 hours for 7 days Drug: fludrocortisone 50 µg once a day via a nasogastric tube for seven days |
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Experimental: 3
Hydrocortisone and intensive insulin therapy
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Drug: recombinant human insulin
intensive insulin therapy as a continuous infusion to maintain blood glucose levels between 4 and 6 mmol/l Drug: hydrocortisone 50 mg as iv bolus every 6 hours for 7 days |
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Experimental: 4
hydrocortisone, fludrocortisone and intensive insulin therapy
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Drug: recombinant human insulin
intensive insulin therapy as a continuous infusion to maintain blood glucose levels between 4 and 6 mmol/l Drug: hydrocortisone 50 mg as iv bolus every 6 hours for 7 days Drug: fludrocortisone 50 µg once a day via a nasogastric tube for seven days |
- In-hospital mortality [ Time Frame: Day 180 ]
- Secondary outcomes : [ Time Frame: Day 180 ]
- 90-day and 180-day mortality. [ Time Frame: Day 180 ]
- Duration of life-supporting treatments (i.e. vasopressors and mechanical ventilation) [ Time Frame: Day 180 ]
- Time to resolve multiple organ dysfunction, i.e. to obtain a SOFA score < 8 [ Time Frame: Day 180 ]
- Hospital length of stay. [ Time Frame: Day 180 ]
- Number of hypoglycaemic events (blood glucose < 4 mmol/l) during insulin infusion [ Time Frame: Day 180 ]
- Muscle weakness at discharge from intensive care unit, 90-day and 180-day [ Time Frame: Day 180 ]
- Post traumatic stress disorders [ Time Frame: Day 180 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients admitted in intensive care units for septic shock and meeting all following criteria
- Proven infection
- Need for vasopressor to maintain systemic arterial tension above 90 mmHg
- Multiple organ dysfunction as defined by a SOFA score ³ 8.
- Need for treatment with moderate dose of corticosteroids
Exclusion Criteria:
One of the following :
- Pregnancy
- Less than 18 years old
- Moribund (i.e. expected to die on day of intensive care unit admission)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320099
| France | |
| Hôpital Avicenne | |
| Bobigny, France | |
| Hôpital Jean Verdier | |
| Bondy, France | |
| CHU Grenoble | |
| Grenoble, France | |
| Hôpital central | |
| Nancy, France | |
| Hôpital Saint Louis | |
| Paris, France, 75 | |
| Hôpital Bichat Claude Bernard | |
| Paris, France | |
| hôpital Cochin | |
| Paris, France | |
| Hôpital Delafontaine | |
| Saint Denis, France, 93 | |
| Study Chair: | Djillali annane, MD, PhD | Assistance Publique Hôpitaux de Paris - University of Versailles |
| Responsible Party: | Djillali Annane, AP-HP - University of Versailles SQY |
| ClinicalTrials.gov Identifier: | NCT00320099 |
| Other Study ID Numbers: |
AOM04100 P040421 |
| First Posted: | May 3, 2006 Key Record Dates |
| Last Update Posted: | April 6, 2010 |
| Last Verified: | April 2010 |
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septic shock adrenal insufficiency glucose control mineralocorticoids |
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Shock, Septic Shock Pathologic Processes Sepsis Infections Systemic Inflammatory Response Syndrome Inflammation Insulin Insulin, Globin Zinc |
Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Fludrocortisone Hypoglycemic Agents Physiological Effects of Drugs Anti-Inflammatory Agents |