Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Baselstadt
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Basel、Baselstadt、スイス、4031
- Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine,
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ: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. |
Comparison of a sliding scale with an intensive s.c.
scale
他の名前:
|
実験的: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. |
Comparison of a sliding scale with an intensive s.c.
scale
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours
時間枠:48 h
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time to Reach the Target Range
時間枠:24 h
|
Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).
|
24 h
|
Frequency of Hypoglycemia
時間枠:during observation of 48 hours
|
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
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Frequency of Severe Hypoglycaemia
時間枠:during observation of 48 hours
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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
|
Frequency of Hypokalaemia
時間枠:during observation of 48 hours
|
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
|
協力者と研究者
捜査官
- 主任研究者:Ulrich Keller, MD, Prof、Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- EKBB13/06
- ISRCTN55224894 (レジストリ識別子:Current Controlled Trials Database)
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