Subarachnoid HemorrhagePhase 4NCT00505505
Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy
A Phase 4 study testing Insulin (Actrapid) in people with Subarachnoid Hemorrhage and Traumatic Brain Injury, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhage
- What is being tested?
- Insulin (Actrapid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2002to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subarachnoid hemorrhage
- Traumatic brain injury
- Intracranial hemorrhage
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Vincenzo Cuzzone contact
Italy1 site, 1 recruiting
- Recruiting
University of Rome La Sapienza
Rome
Federico Bilotta, MD, PhD, bilotta@tiscali.it
About this study
Official title: Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients
Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.
Read the detailed description
Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).
- Being tested
- Insulin (Actrapid)
- Keywords
- Neurointensive care, Intensive insulin infusion, Hypoglycemia, Postoperative Mortality, Postoperative Morbidity, Neurologic outcome
- Medical subject headings
- Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Intracranial Hemorrhages, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin (Actrapid)Drug
50 UI Actrapid diluted in 50 ml of saline
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl Receives: Drug: Insulin (Actrapid) |
| B | Active comparator | Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl Receives: Drug: Insulin (Actrapid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of hypoglycemia
Secondary outcomes (4)
Infection rate
Measured: during the study
Vasospasm rate
Measured: during the study
Mortality
Measured: 6 months follow up
Neurologic status
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Investigators
- Federico Bilotta, MD, PhD, Study chair, Department of Anesthesiology, Critical Care and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505505
- Sponsor's protocol ID
- 1781964
- Status last verified
- Jul 2007
- First submitted
- 20 Jul 2007
- Last updated
- 7 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients
- ClinicalTrials.gov ID
- NCT00505505
- Acronym / sponsor ID
- 1781964
- Keywords
- Neurointensive care, Intensive insulin infusion, Hypoglycemia, Postoperative Mortality, Postoperative Morbidity, Neurologic outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2002
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.
Detailed description
Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Insulin (Actrapid)Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl |
| B | Active comparator | Drug: Insulin (Actrapid)Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subarachnoid hemorrhage
- Traumatic brain injury
- Intracranial hemorrhage
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin (Actrapid)50 UI Actrapid diluted in 50 ml of saline | Drug | A, B |
Primary outcome
Episodes of hypoglycemia
4 secondary outcomes
Infection rate
Time frame: during the study
Vasospasm rate
Time frame: during the study
Mortality
Time frame: 6 months follow up
Neurologic status
Time frame: 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Cuzzone contact
Federico Bilotta, MD, PhD study chair
Department of Anesthesiology, Critical Care and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin (Actrapid) in people with Subarachnoid Hemorrhage and Traumatic Brain Injury, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Bilotta, MD, PhD (39 339 33 708 22, bilotta@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodes of hypoglycemia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2008.