Brain NeoplasmsEarly Phase 1NCT00993057
Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia
A Early Phase 1 study testing Insulin in people with Brain Neoplasms and Intracranial Aneurysm, run by Northwestern University at 1 site in United States.
Trial summary
What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Intracranial Aneurysm
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Aug 2012
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All English speaking, non-diabetic, non-pregnant patients over the age of 18 undergoing open craniotomy for the surgical treatment of tumors or intracranial aneurysms.
Who cannot join
- Patients under 18 years of age, patients who are pregnant, patients with diabetes, BMI > 33 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Two Glucose Sampling Frequencies for an Intensive Insulin Protocol During Craniotomy in Non-Diabetic Patients-How Efficiently and Safely Can We Maintain Target Glucose Levels
What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.
Read the detailed description
Intraoperative blood glucose levels will be maintained in the target range of 90-110 mg/dL (euglycemia) using the protocol. The target serum glucose ranges chosen (90-110 mg/dL) was chosen to specifically target those levels associated with the best outcome in cerebral aneurysm surgery (serum glucose < 108 mg/dL) and aggressively avoid those levels associated with cognitive dysfunction (serum glucose < 128 mg/dL) and gross neurologic deficits (serum glucose < 152 mg/dL). Because the strength of these data, the investigators utilize an aggressive insulin protocol in their routine clinical care of patients undergoing craniotomies.
Each patient will be randomly assigned to one of two frequency of intervention groups-Group 30 will have the insulin dose adjusted every 30 minutes and Group 60 will have the insulin dose adjusted every 60 minutes. Blood glucose levels, insulin boluses and infusion rates, and dextrose boluses will be recorded on the respective Intraoperative Insulin \& Glucose data sheet (Appendix 2 and 3 for Group 30 and Group 60, respectively).
Regardless of the protocol, glucose measurements will be conducted every 15 minutes but insulin intervention will be done at 30 minutes or one hour (per assigned treatment group). The interval data (15 minutes for the 30 min group and 15, 30, and 45 minutes for the 1 hour group) will be utilized to determine the pharmacodynamic effects of insulin (dose-response relationship). Interventions will only be performed at the assigned interval (30 vs 60 min) unless the glucose level is < 70 mg/dL, at which time the patient will receive 25 mL of 50% Dextrose solution. For these rescued patients, the protocol will be continued as scheduled.
On the day of surgery, after confirming entry into the study (i.e., confirmation of research consent), each patient will be randomly assigned to a specific protocol-q 30 minutes glucose measurements and intervention vs. q 60 minutes glucose measurements and intervention.Randomization will be performed in blocks of 10 using a computer generated random number assignment (odd numbers = q 30 minutes and even numbers = q 60 minutes)
- Conditions
- Brain Neoplasms, Intracranial Aneurysm
- Being tested
- Insulin
- Keywords
- Euglycemia, craniotomy, neurosurgery, hypoglycemia, insulin
- Medical subject headings
- Brain Neoplasms, Intracranial Aneurysm, Hypoglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Humulin
Adjustable insulin infusion scale with loading doses
| Study group | Role | What they receive |
|---|---|---|
| Q1 hour protocol | Active comparator | change of insulin infusion every hour Receives: Drug: Insulin |
| Q30min protocol | Active comparator | change of insulin infusion every 30 minutes Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of each of glucose sampling and insulin protocols for achieving euglycemia
performance of each of glucose sampling and insulin protocols for achieving euglycemia during the operation
Measured: duration of operation
Secondary outcomes (4)
hypoglycemia
Hypoglycemia occurring the operation
Measured: duration of operation
time required to reach euglycemia
Elapsed time required to reach euglycemia during the operation
Measured: durarion of operation
relationship of BMI and performance of protocols
Evaluating the relationship of BMI (Body Mass Index) and the performance of protocols during the operation
Measured: duration of operation
relationship of serum biomarkers of insulin resistance and performance of protocols
Evaluating the relationship of serum biomarkers of insulin resistance and performance of protocols during the operation
Measured: duration of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Bebawy, Northwestern University
- Investigators
- Dhanesh Gupta, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993057
- Sponsor's protocol ID
- STU00009023
- Status last verified
- Dec 2019
- First submitted
- 8 Oct 2009
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. doi: 10.1093/bja/aem140.
PubMed 17573393Lukins MB, Manninen PH. Hyperglycemia in patients administered dexamethasone for craniotomy. Anesth Analg. 2005 Apr;100(4):1129-1133. doi: 10.1213/01.ANE.0000146943.45445.55.
PubMed 15781533Lindsberg PJ, Roine RO. Hyperglycemia in acute stroke. Stroke. 2004 Feb;35(2):363-4. doi: 10.1161/01.STR.0000115297.92132.84. No abstract available.
PubMed 14757880Pasternak JJ, McGregor DG, Schroeder DR, Lanier WL, Shi Q, Hindman BJ, Clarke WR, Torner JC, Weeks JB, Todd MM; IHAST Investigators. Hyperglycemia in patients undergoing cerebral aneurysm surgery: its association with long-term gross neurologic and neuropsychological function. Mayo Clin Proc. 2008 Apr;83(4):406-17. doi: 10.4065/83.4.406.
PubMed 18380986Carvalho G, Moore A, Qizilbash B, Lachapelle K, Schricker T. Maintenance of normoglycemia during cardiac surgery. Anesth Analg. 2004 Aug;99(2):319-24, table of contents. doi: 10.1213/01.ANE.0000121769.62638.EB.
PubMed 15271698Geroldi D, Falcone C, Emanuele E. Soluble receptor for advanced glycation end products: from disease marker to potential therapeutic target. Curr Med Chem. 2006;13(17):1971-8. doi: 10.2174/092986706777585013.
PubMed 16842191Meng YX, Ford ES, Li C, Quarshie A, Al-Mahmoud AM, Giles W, Gibbons GH, Strayhorn G. Association of C-reactive protein with surrogate measures of insulin resistance among nondiabetic US from National Health and Nutrition Examination Survey 1999-2002. Clin Chem. 2007 Dec;53(12):2152-9. doi: 10.1373/clinchem.2007.088930. Epub 2007 Oct 19.
PubMed 17951292Olufadi R, Byrne CD. Clinical and laboratory diagnosis of the metabolic syndrome. J Clin Pathol. 2008 Jun;61(6):697-706. doi: 10.1136/jcp.2007.048363.
PubMed 18505888Yamauchi T, Kamon J, Waki H, Terauchi Y, Kubota N, Hara K, Mori Y, Ide T, Murakami K, Tsuboyama-Kasaoka N, Ezaki O, Akanuma Y, Gavrilova O, Vinson C, Reitman ML, Kagechika H, Shudo K, Yoda M, Nakano Y, Tobe K, Nagai R, Kimura S, Tomita M, Froguel P, Kadowaki T. The fat-derived hormone adiponectin reverses insulin resistance associated with both lipoatrophy and obesity. Nat Med. 2001 Aug;7(8):941-6. doi: 10.1038/90984.
PubMed 11479627Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.
PubMed 10195925Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94. doi: 10.1007/BF01143186.
PubMed 1588504
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Glucose Sampling Frequencies for an Intensive Insulin Protocol During Craniotomy in Non-Diabetic Patients-How Efficiently and Safely Can We Maintain Target Glucose Levels
- ClinicalTrials.gov ID
- NCT00993057
- Acronym / sponsor ID
- STU00009023
- Conditions
- Brain Neoplasms, Intracranial Aneurysm
- Keywords
- Euglycemia, craniotomy, neurosurgery, hypoglycemia, insulin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Oct 2009 (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.
What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.
Detailed description
Intraoperative blood glucose levels will be maintained in the target range of 90-110 mg/dL (euglycemia) using the protocol. The target serum glucose ranges chosen (90-110 mg/dL) was chosen to specifically target those levels associated with the best outcome in cerebral aneurysm surgery (serum glucose < 108 mg/dL) and aggressively avoid those levels associated with cognitive dysfunction (serum glucose < 128 mg/dL) and gross neurologic deficits (serum glucose < 152 mg/dL). Because the strength of these data, the investigators utilize an aggressive insulin protocol in their routine clinical care of patients undergoing craniotomies.
Each patient will be randomly assigned to one of two frequency of intervention groups-Group 30 will have the insulin dose adjusted every 30 minutes and Group 60 will have the insulin dose adjusted every 60 minutes. Blood glucose levels, insulin boluses and infusion rates, and dextrose boluses will be recorded on the respective Intraoperative Insulin \& Glucose data sheet (Appendix 2 and 3 for Group 30 and Group 60, respectively).
Regardless of the protocol, glucose measurements will be conducted every 15 minutes but insulin intervention will be done at 30 minutes or one hour (per assigned treatment group). The interval data (15 minutes for the 30 min group and 15, 30, and 45 minutes for the 1 hour group) will be utilized to determine the pharmacodynamic effects of insulin (dose-response relationship). Interventions will only be performed at the assigned interval (30 vs 60 min) unless the glucose level is < 70 mg/dL, at which time the patient will receive 25 mL of 50% Dextrose solution. For these rescued patients, the protocol will be continued as scheduled.
On the day of surgery, after confirming entry into the study (i.e., confirmation of research consent), each patient will be randomly assigned to a specific protocol-q 30 minutes glucose measurements and intervention vs. q 60 minutes glucose measurements and intervention.Randomization will be performed in blocks of 10 using a computer generated random number assignment (odd numbers = q 30 minutes and even numbers = q 60 minutes)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q1 hour protocol | Active comparator | Drug: Insulinchange of insulin infusion every hour |
| Q30min protocol | Active comparator | Drug: Insulinchange of insulin infusion every 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All English speaking, non-diabetic, non-pregnant patients over the age of 18 undergoing open craniotomy for the surgical treatment of tumors or intracranial aneurysms.
Key exclusion criteria (1 listed)
- Patients under 18 years of age, patients who are pregnant, patients with diabetes, BMI > 33 kg/m2.
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 |
|---|---|---|
| InsulinAlso: HumulinAdjustable insulin infusion scale with loading doses | Drug | Q1 hour protocol, Q30min protocol |
Primary outcome
performance of each of glucose sampling and insulin protocols for achieving euglycemia
Time frame: duration of operation
performance of each of glucose sampling and insulin protocols for achieving euglycemia during the operation
4 secondary outcomes
hypoglycemia
Time frame: duration of operation
time required to reach euglycemia
Time frame: durarion of operation
relationship of BMI and performance of protocols
Time frame: duration of operation
relationship of serum biomarkers of insulin resistance and performance of protocols
Time frame: duration of operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Background: PubMed 17573393Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. doi: 10.1093/bja/aem140.
- Background: PubMed 15781533Lukins MB, Manninen PH. Hyperglycemia in patients administered dexamethasone for craniotomy. Anesth Analg. 2005 Apr;100(4):1129-1133. doi: 10.1213/01.ANE.0000146943.45445.55.
- Background: PubMed 14757880Lindsberg PJ, Roine RO. Hyperglycemia in acute stroke. Stroke. 2004 Feb;35(2):363-4. doi: 10.1161/01.STR.0000115297.92132.84. No abstract available.
- Background: PubMed 18380986Pasternak JJ, McGregor DG, Schroeder DR, Lanier WL, Shi Q, Hindman BJ, Clarke WR, Torner JC, Weeks JB, Todd MM; IHAST Investigators. Hyperglycemia in patients undergoing cerebral aneurysm surgery: its association with long-term gross neurologic and neuropsychological function. Mayo Clin Proc. 2008 Apr;83(4):406-17. doi: 10.4065/83.4.406.
- Background: PubMed 15271698Carvalho G, Moore A, Qizilbash B, Lachapelle K, Schricker T. Maintenance of normoglycemia during cardiac surgery. Anesth Analg. 2004 Aug;99(2):319-24, table of contents. doi: 10.1213/01.ANE.0000121769.62638.EB.
- Background: PubMed 16842191Geroldi D, Falcone C, Emanuele E. Soluble receptor for advanced glycation end products: from disease marker to potential therapeutic target. Curr Med Chem. 2006;13(17):1971-8. doi: 10.2174/092986706777585013.
- Background: PubMed 17951292Meng YX, Ford ES, Li C, Quarshie A, Al-Mahmoud AM, Giles W, Gibbons GH, Strayhorn G. Association of C-reactive protein with surrogate measures of insulin resistance among nondiabetic US from National Health and Nutrition Examination Survey 1999-2002. Clin Chem. 2007 Dec;53(12):2152-9. doi: 10.1373/clinchem.2007.088930. Epub 2007 Oct 19.
- Background: PubMed 18505888Olufadi R, Byrne CD. Clinical and laboratory diagnosis of the metabolic syndrome. J Clin Pathol. 2008 Jun;61(6):697-706. doi: 10.1136/jcp.2007.048363.
- Background: PubMed 11479627Yamauchi T, Kamon J, Waki H, Terauchi Y, Kubota N, Hara K, Mori Y, Ide T, Murakami K, Tsuboyama-Kasaoka N, Ezaki O, Akanuma Y, Gavrilova O, Vinson C, Reitman ML, Kagechika H, Shudo K, Yoda M, Nakano Y, Tobe K, Nagai R, Kimura S, Tomita M, Froguel P, Kadowaki T. The fat-derived hormone adiponectin reverses insulin resistance associated with both lipoatrophy and obesity. Nat Med. 2001 Aug;7(8):941-6. doi: 10.1038/90984.
- Background: PubMed 10195925Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.
- Background: PubMed 1588504Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94. doi: 10.1007/BF01143186.
- Individual participant dataSharing planned: No
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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.
Dhanesh Gupta, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Insulin in people with Brain Neoplasms and Intracranial Aneurysm, run by Northwestern University at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Dec 2019. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of each of glucose sampling and insulin protocols for achieving euglycemia (time frame: duration of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993057, which also lists 11 linked publications.
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 13 Dec 2019.