Hyperinsulinemic Therapy in Sepsis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01244178

Enrollment

Registered

2010-11-19

Start date

2010-11-30

Completion date

Unknown

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Sepsis, Insulin

Brief summary

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.

Interventions

DRUGInsulin

Intravenous Hyperinsulinemic therapy

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Glucose Control	During ICU stay (average one week)	Measures glucose control using the hyperinsulinemic/normoglycemic clamp in patients with septic shock

Secondary

Measure	Time frame	Description
Inflammatory cytokines and biochemical hormonal response	At randomization then at 6,24, 120 hours	Measurement of specific cytokines and hormonal responses to hyperinsulinemic therapy in patients with septic shock

Countries

Canada, Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026