MAP- Versus Cardiac Index-Guided Hemodynamic Management in Whipple Surgery
Comparison of the Effects of Mean Arterial Pressure-Based and Cardiac Index-Based Intraoperative Hemodynamic Management on Postoperative Renal Function in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Study
This prospective randomized study aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing pancreaticoduodenectomy. Patients will be allocated to either mean arterial pressure-guided hemodynamic management or cardiac index-guided hemodynamic management during surgery.
Pancreaticoduodenectomy is a major abdominal surgical procedure associated with prolonged operative duration, considerable fluid shifts, blood loss, and hemodynamic instability. These factors may contribute to impaired renal perfusion and postoperative renal dysfunction. Although mean arterial pressure is commonly used to guide intraoperative hemodynamic management, blood pressure alone may not fully reflect systemic blood flow or tissue perfusion. Cardiac index-guided management may provide a more direct assessment of global circulatory adequacy.
The primary outcome of the study is the change in serum creatinine level from the preoperative baseline value to the postoperative 72nd hour. Secondary outcomes include intraoperative hemodynamic variables, fluid and vasopressor requirements, urine output, postoperative renal function parameters, length of intensive care unit and hospital stay, and 30-day mortality.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Atakan Sezgi
- 전화번호: 00905323327000
- 이메일: kansezgi@gmail.com
연구 연락처 백업
- 이름: Musa Zengin
- 전화번호: 00905307716235
- 이메일: musazengin@gmail.com
연구 장소
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Ankara
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Çankaya, Ankara, 터키 (Türkiye), 06170
- 모병
- Ankara Etlik City Hospital
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연락하다:
- Musa Zengin, Associate Professor
- 전화번호: 00905307716235
- 이메일: musazengin@gmail.com
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연락하다:
- Atakan Sezgi, M.D.
- 전화번호: 00905323327000
- 이메일: kansezgi@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18 to 80 years
- Patients with American Society of Anesthesiologists physical status II-III
- Patients with estimated glomerular filtration rate ≥60 mL/min/1.73 m²
- Patients scheduled for pancreaticoduodenectomy / Whipple procedure
- Patients who provide written informed consent
Exclusion Criteria:
- Patients younger than 18 years or older than 80 years
- Patients with estimated glomerular filtration rate <60 mL/min/1.73 m²
- Patients with American Society of Anesthesiologists physical status other than II-III
- Patients who refuse to participate in the study
- Patients who withdraw consent at any stage of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Mean Arterial Pressure-Guided Hemodynamic Management
Patients in this group will receive intraoperative hemodynamic management based on predefined mean arterial pressure targets.
Hemodynamic interventions, including fluid administration, vasopressor therapy, and other standard intraoperative management strategies, will be guided primarily by mean arterial pressure values.
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Intraoperative hemodynamic management will be performed according to predefined mean arterial pressure targets during pancreaticoduodenectomy.
Standard anesthetic care, fluid therapy, vasopressor use, and intraoperative monitoring will be applied according to institutional clinical practice.
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활성 비교기: Cardiac Index-Guided Hemodynamic Management
Patients in this group will receive intraoperative hemodynamic management based on predefined cardiac index targets.
Hemodynamic interventions, including fluid administration, vasopressor or inotrope therapy, and other standard intraoperative management strategies, will be guided primarily by cardiac index values.
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Intraoperative hemodynamic management will be performed according to predefined cardiac index targets during pancreaticoduodenectomy.
Cardiac index values will be monitored intraoperatively, and fluid therapy, vasopressor use, and inotrope administration will be adjusted according to the hemodynamic status of the patient and institutional clinical practice.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in serum creatinine level from baseline to postoperative 72 hours
기간: Preoperative baseline and postoperative 72nd hour
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The primary outcome is the change in serum creatinine level, calculated as the difference between the serum creatinine value measured at postoperative 72 hours and the preoperative baseline serum creatinine value.
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Preoperative baseline and postoperative 72nd hour
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Intraoperative urine output
기간: From anesthesia induction to the end of surgery
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Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour.
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From anesthesia induction to the end of surgery
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Total intraoperative fluid administration
기간: From anesthesia induction to the end of surgery
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The total amount of crystalloid and colloid fluids administered intraoperatively will be recorded.
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From anesthesia induction to the end of surgery
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Postoperative serum creatinine levels
기간: Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
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Serum creatinine values will be recorded at predefined postoperative time points to evaluate renal function trends during the early postoperative period.
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Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 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. .
휘플 시술에 대한 임상 시험
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Centre Hospitalier Universitaire de Nice완전한십이지장 다각화 | 유문 배제 | 위공장문합술 | 역행성 십이지장절개술 | 원위 공급 튜브 | 절제술 및 Whipple 절차 | 1차 수리프랑스