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Hyperinsulinemic Therapy in Sepsis

P

peter metrakos

Status

Unknown

Conditions

Sepsis

Treatments

Drug: Insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT01244178
10-003-GEN

Details and patient eligibility

About

Insulin regulates blood sugar and acts to suppress inflammation. Hyperinsulinemic Therapy is a protocol for Insulin administration that involves the administration of a calculated higher dose of insulin into the blood stream. This therapy is called dextrose/insulin clamp. It has been shown to be safe and successful in maintaining normal glucose levels.

The objective of the study is to assess if the clamp can achieve a steady and normal blood glucose level in patients admitted to the intensive care unit with sepsis. Furthermore, if the higher insulin dose would lead to a drop in the inflammatory response seen in septic patients.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis.

Exclusion criteria

  • Age less than 18 years old.
  • Pregnancy.
  • Patients who cannot provide informed consent and there is no surrogate decision maker.
  • A delay of more than 24 hours between eligibility and randomization.
  • Patients admitted to the intensive care unit for treatment of diabetic ketoacidosis or hyperosmolar state.
  • Imminent death.
  • Patients who the treating clinicians are not committed to full supportive care. This is confirmed by a documented treatment-limitation order that exceeds a "do-not-resuscitation" order.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

15 participants in 3 patient groups

Tight Glucose Control Hyperinsulinemic Group
Experimental group
Treatment:
Drug: Insulin
Drug: Insulin
Non-Tight Glucose Control Hyperinsulinemic Group
Experimental group
Treatment:
Drug: Insulin
Drug: Insulin
Standard Insulin Protocol Group
Active Comparator group
Treatment:
Drug: Insulin
Drug: Insulin

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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