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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00353431
First received: July 17, 2006
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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)


Condition Intervention
Hyperglycemias
Drug: Novorapid ®, Novo Nordisk, Denmark

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)


Secondary Outcome Measures:
  • Time to Reach the Target Range [ Time Frame: 24 h ] [ Designated as safety issue: No ]
    Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).

  • Frequency of Hypoglycemia [ Time Frame: during observation of 48 hours ] [ Designated as safety issue: Yes ]
    absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)

  • Frequency of Severe Hypoglycaemia [ Time Frame: during observation of 48 hours ] [ Designated as safety issue: Yes ]
    Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)

  • Frequency of Hypokalaemia [ Time Frame: during observation of 48 hours ] [ Designated as safety issue: Yes ]
    Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)


Enrollment: 130
Study Start Date: December 2006
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

Conventional insulin group:

In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.

Drug: Novorapid ®, Novo Nordisk, Denmark
Comparison of a sliding scale with an intensive s.c. scale
Other Names:
  • insulin aspart,
  • Novolog
Experimental: 2

Intensive insulin therapy algorithm:

The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.

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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353431

Locations
Switzerland
Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine,
Basel, Baselstadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Ulrich Keller, MD, Prof Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00353431     History of Changes
Other Study ID Numbers: EKBB13/06, ISRCTN55224894
Study First Received: July 17, 2006
Results First Received: October 31, 2011
Last Updated: May 10, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Hyperglycaemia
algorithm
emergency
s.c. insulin therapy
Emergency patient

Additional relevant MeSH terms:
Emergencies
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014