- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02661269
Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity
Can videomicroscopy of the sublingual microcirculation detect the increase in edema before peripheral edema will appear? By measuring the decrease in vesseldensity after strong positive fluid balances within septic patients versus euvolemic post-cardiac surgery patients. Measuring reactance and resistance (BIVA method) to determine volume status.
Primary outcome:
- Total vessel density (TVD)
Secondary outcome:
- Fluid balance
- BIVA measurements (reactance & resistance)
연구 개요
상태
상세 설명
There are a lot of methods to determine if a patient is fluid-responsive, however a moment to stop fluid therapy is lacking. So the purpose of this study is to find a 'stop' moment for fluid therapy before peripheral edema will be present.
With sublingual measurements of the vessel density with the Cytocam-IDF, comparing the septic patients with fluid overload , euvolemic post-cardiac surgery patients at the arrival on the ICU and healthy volunteers we can determine if there is a decrease in vessel density during fluid loading.
To give a accurate view on fluid overload we include a bio-impedance measurement of reactance and resistance. Fluid balances are recorded very accurate by our electronic patient record.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
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Friesland
-
Leeuwarden, Friesland, 네덜란드, 8901 BR
- Medical Centre Leeuwarden
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- after cardiac surgery
- septic patient with a fluid balance of 4L +
Exclusion Criteria:
- recent maxillofacial surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Septic patients
Septic patients with fluid overload (fluid balance + 4 L)
|
Measuring total vessel density with the Cytocam-IDF camera.
measuring resistance and reactance with the BIVA method.
|
|
Post-cardiac surgery patients
Patients after cardiac surgery, at arrival on ICU.
|
Measuring total vessel density with the Cytocam-IDF camera.
measuring resistance and reactance with the BIVA method.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.
기간: Cardiac surgery within 4 hours of ICU admittance, 1 offline total vessel density measurement, Septic patients +/- third day of ICU admittance, 1 offline total vessel density measurement.
|
With the Cytocam-IDF we make movies off the sublingual microcirculation for 6 seconds on 3 different spots, with offline analysis we calculate a mean total vessel density (total surface of vessels divided by total area surface). The cardiac surgery group will be measured within 4 hours of admittance on the ICU. The septic patients group will be measured on the moment that the highest fluid balance during the ICU stay, so on the moment that there will be started with diuretics of renal replacement therapy to induce a negative fluid balance. |
Cardiac surgery within 4 hours of ICU admittance, 1 offline total vessel density measurement, Septic patients +/- third day of ICU admittance, 1 offline total vessel density measurement.
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
The correlation between a increasing fluid balance and the total vessel density in both groups separately.
기간: The cumulative fluidbalance (L) will be noted at the same moment as the microcirculation movies are made, this will be the cumulative fluid balance as measured on the ICU.
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The cumulative fluidbalance (L) will be noted at the same moment as the microcirculation movies are made, this will be the cumulative fluid balance as measured on the ICU.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: E.C. Boerma, MD-PhD, Medical Centre Leeuwarden
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- nWMO 127
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