NCT00993057

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2009

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

October 8, 2009

Last Update Submit

December 11, 2019

Conditions

Brain NeoplasmsIntracranial Aneurysm

Keywords

Euglycemiacraniotomyneurosurgeryhypoglycemiainsulin

Outcome Measures

Primary Outcomes (1)

  • 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

    duration of operation

Secondary Outcomes (4)

  • hypoglycemia

    duration of operation

  • time required to reach euglycemia

    durarion of operation

  • relationship of BMI and performance of protocols

    duration of operation

  • relationship of serum biomarkers of insulin resistance and performance of protocols

    duration of operation

Study Arms (2)

Q1 hour protocol

ACTIVE COMPARATOR

change of insulin infusion every hour

Drug: Insulin

Q30min protocol

ACTIVE COMPARATOR

change of insulin infusion every 30 minutes

Drug: Insulin

Interventions

InsulinDRUG

Adjustable insulin infusion scale with loading doses

Also known as: Humulin
Q1 hour protocolQ30min protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 years of age, patients who are pregnant, patients with diabetes, BMI \> 33 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhanesh Gupta

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

  • Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. doi: 10.1093/bja/aem140.

    PMID: 17573393BACKGROUND

  • Lukins 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.

    PMID: 15781533BACKGROUND

  • Lindsberg 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.

    PMID: 14757880BACKGROUND

  • Pasternak 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.

    PMID: 18380986BACKGROUND

  • Carvalho 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.

    PMID: 15271698BACKGROUND

  • Geroldi 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.

    PMID: 16842191BACKGROUND

  • Meng 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.

    PMID: 17951292BACKGROUND

  • Olufadi 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.

    PMID: 18505888BACKGROUND

  • Yamauchi 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.

    PMID: 11479627BACKGROUND

  • Yudkin 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.

    PMID: 10195925BACKGROUND

  • Varvel 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.

    PMID: 1588504BACKGROUND

MeSH Terms

Conditions

Brain NeoplasmsIntracranial AneurysmHypoglycemiaInsulin Resistance

Interventions

InsulinInsulin, Regular, Human

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersAneurysmVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Dhanesh Gupta, MD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Anesthesiology and Neurological Surgery

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)