Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

Hyperglycemias Clinical Trial

Official title:

Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353431
• Other study ID #: EKBB13/06
• Secondary ID: ISRCTN55224894
• Status: Completed
• Phase: N/A
• First received: July 17, 2006
• Last updated: May 10, 2012
• Start date: December 2006
• Est. completion date: October 2010

Study information

• Verified date: May 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l)

Description:

BACKGROUND: Prospective randomized trials have shown that near-normoglycemic blood glucose control using insulin infusions achieves a significant reduction in mortality of severely ill patients in intensive care units, of patients with acute myocardial infarction and with stroke. This implies that most severely ill patients with hyperglycemia should be treated with insulin to reach near-normoglycemia. However, this is not common practice today in emergency room admissions outside the intensive care unit, and strategies to achieve near-normoglycemia safely outside the ICU setting with s.c. injections (insulin infusions are too risky outside the ICU) have not been established.

AIM: To evaluate an insulin therapy algorithm using s.c. injections which permits effective and safe glycemic management of emergency room patients with hyperglycemia.

DESIGN: Randomized, controlled trial with an open intervention. Patients presenting with hyperglycemia on admission to the emergency room are randomized 1:1 either to conventional treatment (conventional insulin group) or to intensive treatment (intensive insulin group).

METHODS: 140 patients admitted to the medical emergency rooms of the University Hospital Basel and the Regional Hospital of Solothurn will be included and randomized as described above. All patients with plasma glucose levels exceeding 8.0 mmol/l will be included.

Exclusion criteria include severely immunocompromised patients, patients in shock, patients with terminal illnesses on palliative care, type 1 diabetes with or without ketoacidosis and patients which require intensive care unit (ICU) or cardial care unit (CCU) therapy.

PRIMARY ENDPOINT: Time in the glycaemic target range (5.5-7.0 mmol/l) during the period of observation of 48 hours (expected to be longer in the intensive insulin group)

SECONDARY ENDPOINTS: Time to reach the target range. Frequency of hypoglycaemia (plasma glucose < 3.8 mmol/l). Frequency of severe hypoglycaemia (plasma glucose < 2.5 mmol/l. Frequency of hypokalaemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients with hyperglycaemia (= 8.0 mmol/l) admitted to the medical emergency room.

• patients with presumed hospitalisation in ER or medical ward of more than 48 h duration.

Exclusion Criteria:

• patients in shock (defined as hypotension or shock index > 1 with oliguria, changed mental status and metabolic acidosis)

• patients with a terminal illness on palliative care

• patients with type 1 diabetes

• patients with insulin pump therapy

• patients with need for hospitalisation in the intensive or coronary care unit.

• patients with presumed hospitalisation shorter than 48 hours

• known pregnancy (in women with childbearing potential pregnancy test for exclusion mandatory)

• no informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Hyperglycemia
• Hyperglycemias

Intervention

Drug:
• Novorapid ®, Novo Nordisk, Denmark
Comparison of a sliding scale with an intensive s.c. scale

Locations

Country	Name	City	State
Switzerland	Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine,	Basel	Baselstadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours	Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)	48 h	No
Secondary	Time to Reach the Target Range	Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).	24 h	No
Secondary	Frequency of Hypoglycemia	absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)	during observation of 48 hours	Yes
Secondary	Frequency of Severe Hypoglycaemia	Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)	during observation of 48 hours	Yes
Secondary	Frequency of Hypokalaemia	Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)	during observation of 48 hours	Yes