Status:

COMPLETED

Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)

Lead Sponsor:

King Faisal Specialist Hospital & Research Center

Conditions:

Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Hyperglycemia increases the risk of complications in surgical patients. Focus on poor glycemic control as a contributor to adverse outcomes in settings outside the intensive care unit (ICU) is often d...

Eligibility Criteria

Inclusion

  • All adult diabetic patients undergoing abdominal surgery operated by the surgical oncology team at KFSH \& RC and required TPN therapy are possible subjects of the study.

Exclusion

  • Patients receiving octreotide or immunosuppressive agents including corticosteroids.
  • Recipient of \< 3 units of regular insulin per day via subcutaneous insulin sliding scale after the third day of TPN recipient.
  • Patients with clinically relevant hepatic disease (\> three times normal AST and ALT on admission to the hospital) or impaired renal function (GFR \< 60 ml/min), history of diabetic ketoacidosis.
  • Patients who get infected while on TPN as reflected with elevation of white blood cells and elevated temperature \> 37.5 C will be excluded as well.

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2015

Estimated Enrollment :

61 Patients enrolled

Trial Details

Trial ID

NCT02216799

Start Date

March 1 2013

End Date

August 1 2015

Last Update

February 25 2016

Active Locations (1)

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King Faisal Specialist Hospital & Research Centre

Riyadh, Riyadh Region, Saudi Arabia, 11211