NCT02999386

Brief Summary

The clinical relevance of the observed stress induced hyperglycemia in trauma patients remains unclear. The earlier studies suggested the implications of cytokines in stress induced hyperglycemia and the outcomes after trauma. To date, there is little information available regarding the effect of diabetic hyperglycemia (occult or known) on outcomes after trauma and whether these patients represent a distinct group with differential outcomes when compared to those with stress-induced hyperglycemia. Herein, the purpose of this study is to identify the incidence of stress induced hyperglycemia as well as diabetic hyperglycemia in trauma patients and to investigate the association between proinflammatory cytokine levels and hyperglycemia in our trauma population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

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, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

December 15, 2016

Last Update Submit

July 22, 2020

Conditions

Keywords

stress, hyperglycemia, inflammatory markers, trauma, HbA1cinterleukin-6

Outcome Measures

Primary Outcomes (1)

  • All cause Mortality

    30 days

Secondary Outcomes (4)

  • Pneumonia

    30 days

  • Sepsis

    30 days

  • Multiorgan failure

    30 days

  • Hospital length of stay

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult (≥18 years) trauma patients required hospital admission will be screened for participation in this study.

You may qualify if:

  • All adult (≥18 years) male and female trauma patients consented for participation and have been investigated for random plasma glucose level and HbA1C measured within 5 hours of hospital admission will be included in the study.

You may not qualify if:

  • Patients who descend to participate or in whom random serum glucose level and HbA1C not measured within 5 hours of hospital admission will be excluded from the study.
  • Also, vulnerable populations (children, and pregnant women), and alcoholics will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Coorporation

Doha, 3050, Qatar

Location

Related Publications (10)

  • McCowen KC, Malhotra A, Bistrian BR. Stress-induced hyperglycemia. Crit Care Clin. 2001 Jan;17(1):107-24. doi: 10.1016/s0749-0704(05)70154-8.

    PMID: 11219223BACKGROUND
  • Yendamuri S, Fulda GJ, Tinkoff GH. Admission hyperglycemia as a prognostic indicator in trauma. J Trauma. 2003 Jul;55(1):33-8. doi: 10.1097/01.TA.0000074434.39928.72.

    PMID: 12855878BACKGROUND
  • Laird AM, Miller PR, Kilgo PD, Meredith JW, Chang MC. Relationship of early hyperglycemia to mortality in trauma patients. J Trauma. 2004 May;56(5):1058-62. doi: 10.1097/01.ta.0000123267.39011.9f.

    PMID: 15179246BACKGROUND
  • Kerby JD, Griffin RL, MacLennan P, Rue LW 3rd. Stress-induced hyperglycemia, not diabetic hyperglycemia, is associated with higher mortality in trauma. Ann Surg. 2012 Sep;256(3):446-52. doi: 10.1097/SLA.0b013e3182654549.

    PMID: 22868366BACKGROUND
  • Bosarge PL, Shoultz TH, Griffin RL, Kerby JD. Stress-induced hyperglycemia is associated with higher mortality in severe traumatic brain injury. J Trauma Acute Care Surg. 2015 Aug;79(2):289-94. doi: 10.1097/TA.0000000000000716.

    PMID: 26218699BACKGROUND
  • Rovlias A, Kotsou S. The influence of hyperglycemia on neurological outcome in patients with severe head injury. Neurosurgery. 2000 Feb;46(2):335-42; discussion 342-3. doi: 10.1097/00006123-200002000-00015.

    PMID: 10690722BACKGROUND
  • Wei Y, Chen K, Whaley-Connell AT, Stump CS, Ibdah JA, Sowers JR. Skeletal muscle insulin resistance: role of inflammatory cytokines and reactive oxygen species. Am J Physiol Regul Integr Comp Physiol. 2008 Mar;294(3):R673-80. doi: 10.1152/ajpregu.00561.2007. Epub 2007 Dec 19.

    PMID: 18094066BACKGROUND
  • Esposito K, Marfella R, Giugliano D. Plasma interleukin-18 concentrations are elevated in type 2 diabetes. Diabetes Care. 2004 Jan;27(1):272. doi: 10.2337/diacare.27.1.272. No abstract available.

    PMID: 14694002BACKGROUND
  • Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.

    PMID: 19465235BACKGROUND
  • El-Menyar A, Asim M, Mir F, Hakim S, Kanbar A, Siddiqui T, Younis B, Ahmed K, Mahmood I, Atique S, Al Jogol H, Taha I, Mustafa F, Alabdallat M, Abdelrahman H, Peralta R, Al-Thani H. Patterns and Effects of Admission Hyperglycemia and Inflammatory Response in Trauma Patients: A Prospective Clinical Study. World J Surg. 2021 Sep;45(9):2670-2681. doi: 10.1007/s00268-021-06190-5. Epub 2021 Jun 11.

MeSH Terms

Conditions

Wounds and InjuriesDiabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ayman El-Menyar, MD

    Hamad Medical Coorporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 21, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Only the lead PI will have the access to the data which will be coded with subject identifier to ensure data safety and confidentiality. The study will be opened for collaboration with multi-centers. Data from other centers will be shared with the Lead PI.

Locations