수술 중 유체 도전 및 플라즈마 볼륨 (FC-VE)
복강경 수술 시 혈장량과 혈류역학 최적화를 위한 알부민과 링거 용액의 비교.
A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.
연구 개요
상태
상세 설명
60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight.
Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Östergötland County
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Norrköping, Östergötland County, 스웨덴, 60379
- Vrinnevi Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Written consent to participate in the study
- For women: relevant contraceptive, menopausal or a negative pregnancy test.
- ASA category I to III
- Laparoscopic abdominal surgery, with a duration of at least 90 minutes.
- 18 to 85 years
Exclusion Criteria:
- Patients with known cardiac failure
- <18 or >85 years
- known allergy to albumin
- extracellular hyperhydration or hypervolemia
- kidney failure
- pregnancy or planned pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: acetated Ringers
The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied. |
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first fluid bolus is infused. Circulatory and volume effects are studied. If cardiac output increase a second bolus is infused and studied.
다른 이름들:
|
|
실험적: albumin 5%
The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied. |
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
다른 이름들:
|
|
실험적: albumin 20%
The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied. |
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Plasma volume expansion after a fluid bolus
기간: 60 minutes after an intravenous fluid bolus
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Plasma volume using hemoglobin as an indicator of dilution |
60 minutes after an intravenous fluid bolus
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fluid Balance
기간: 18 to 24 hours
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Calculations of fluid balance |
18 to 24 hours
|
|
Stroke Volume
기간: 60 minutes after an intravenous fluid bolus
|
Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM)) |
60 minutes after an intravenous fluid bolus
|
|
Arterial Blood Pressure
기간: 60 minutes after an intravenous fluid bolus
|
Mean Arterial Pressure, measured with an arterial line. |
60 minutes after an intravenous fluid bolus
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Heart Rate
기간: 60 minutes after an intravenous fluid bolus
|
Heart rate, measured with ECG and pulseoximeter. |
60 minutes after an intravenous fluid bolus
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Bioimpedance
기간: 18 to 24 hours
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Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments. |
18 to 24 hours
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Serum Creatinin
기간: 18 to 24 hours
|
Serum Creatinin as a measure of kidney function |
18 to 24 hours
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arterial pH
기간: 60 minutes after an intravenous fluid bolus
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Influence of a fluid bolus on arterial blood gases |
60 minutes after an intravenous fluid bolus
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arterial Base Excess
기간: 60 minutes after an intravenous fluid bolus
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Influence of a fluid bolus on arterial blood gases |
60 minutes after an intravenous fluid bolus
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arterial serum sodium
기간: 60 minutes after an intravenous fluid bolus
|
Influence of a fluid bolus on Sodium concentration |
60 minutes after an intravenous fluid bolus
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arterial serum chloride
기간: 60 minutes after an intravenous fluid bolus
|
Influence of a fluid bolus on Chloride concentrations |
60 minutes after an intravenous fluid bolus
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Joachim Zdolsek, MD PhD, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
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 (실제)
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
- 비뇨생식기 질환
- 비뇨생식기 신생물
- 부위별 신생물
- 남성 비뇨 생식기 질환
- 비뇨기과 질환
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 장 질환
- 위장관 신생물
- 소화계 신생물
- 소화기계 질환
- 위장병
- 장 신생물
- 직장 질환
- 결장 질환
- 신생물
- 대장 신생물
- 비뇨기과 신생물
- 아미노산, 펩티드 및 단백질
- 단백질
- 알부민
- 링거의 아세테이트
- zidovudine 5'-monophosphate-mannose-albumin conjugate
- galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20
기타 연구 ID 번호
- FC-VE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual de-identified results will be shared, when results are published.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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