Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients (RESCUEII)
Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients; a Randomized Controlled Trial (RESCUEII)
연구 개요
상세 설명
Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:
- Better insight in the alterations of the blood glucose levels
- Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
- Fewer blood samples
- Decreased workload for the nursing staff
In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.
Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.
The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.
In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of <2.2 or >25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.
Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드
- Onze Lieve Vrouwe Gasthuis
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ICU-patients > 18 years
- Expected length of stay on the ICU > 24 hours
- Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- Availability of the Freestyle Navigator
Exclusion Criteria:
- Participation in another trial subject to the WMO
- Lack of informed consent
- Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht <0,20 of > 0,65; paracetamol intoxication)
- Contraindication for placement of the subcutaneous glucose sensor
- Participation in this trial during previous ICU admittance
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Freestyle group
Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU
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Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
다른 이름들:
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활성 비교기: AccuChek group
Glucose levels are being measured by the AccuChek.
Patients also get a Freestyle Navigator, which will be blinded.
The device will stay on the patient up to 5 days, or until discharge from the ICU.
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Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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인류
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Length of stay in the ICU
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Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
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The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
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Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
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The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
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- Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)
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Mean Absolute Glucose change per hour: ΔBGA / Δtime The MAG is calculated by taking the sum of all absolute glucose changes during admission (measured by BGA) and dividing this by the total time spent in the ICU in hours. |
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False positive frequency of alarms of the Freestyle Navigator®
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Verified by the glucose level measurements by blood gas analyzer
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Number of undesirable low glucose levels per 24 hours
기간: 24 hours
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blood glucose levels between 2,5 and 5 mmol/l
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24 hours
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Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
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Number of blood samples per day
기간: 24 hours
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24 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: P HJ van der Voort, MD, PhD, Onze Lieve Vrouwe Gasthuis
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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