- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07565649
Impact of Systematic Point-of-Care Ultrasound Implementation on Clinical Outcomes and Survival in Septic Shock: A Retrospective Single-Center Cohort Study (SHOCK)
Impact of Systematic Implementation of Point-of-Care Ultrasound on Clinical Course and Survival in Patients With Septic Shock: A Retrospective Single-Center Cohort Study
This study aims to evaluate the clinical impact of the systematic implementation of point-of-care ultrasound (POCUS) in the management of patients with septic shock in the intensive care unit (ICU).
Septic shock is associated with high morbidity and mortality, and its management requires timely and accurate hemodynamic assessment. Traditional monitoring methods have limitations in evaluating cardiac function, fluid responsiveness, and tissue perfusion. POCUS provides real-time, bedside, non-invasive assessment that may improve clinical decision-making.
This is a retrospective, single-center cohort study comparing two time periods: a pre-implementation cohort (2016-2019) and a post-implementation cohort (2022-2025), excluding the COVID-19 pandemic period. The primary objective is to assess whether the implementation of POCUS is associated with an improvement in early organ dysfunction, measured as the change in SOFA score at 48 hours (delta SOFA). Secondary outcomes include mortality at 28, 60, and 90 days, incidence of acute kidney injury, duration of organ support therapies, and length of ICU and hospital stay.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Navarre
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Pamplona, Navarre, 스페인, 31008
- Clinica Universidad de Navarra
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥18 years
- Admission to the intensive care unit (ICU) with a clinical diagnosis or suspicion of septic shock
- Microbiological confirmation of infection during clinical course
- Availability of data required to calculate SOFA score at ICU admission and at 48 hours
Exclusion Criteria:
- ICU admissions during the period 2020-2021
- Readmissions related to the same episode of septic shock
- Missing data required for SOFA score calculation
- Patients with limitation of life-sustaining therapies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Pre-POCUS Cohort
Patients admitted to the ICU with septic shock between January 2016 and December 2019, before the systematic implementation of point-of-care ultrasound (POCUS).
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Post-POCUS Cohort
Patients admitted to the ICU with septic shock between January 2022 and December 2025, after the systematic implementation of point-of-care ultrasound (POCUS).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in SOFA score at 48 hours (Delta SOFA)
기간: Baseline (ICU admission) and 48 hours after ICU admission
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Difference between the Sequential Organ Failure Assessment (SOFA) score at ICU admission and at 48 hours.
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Baseline (ICU admission) and 48 hours after ICU admission
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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28-day mortality
기간: Up to 28 days after ICU admission
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All-cause mortality within 28 days from ICU admission
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Up to 28 days after ICU admission
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60-day mortality
기간: Up to 60 days after ICU admission
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All-cause mortality within 60 days from ICU admission
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Up to 60 days after ICU admission
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90-day mortality
기간: Up to 90 days after ICU admission
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All-cause mortality within 90 days from ICU admission
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Up to 90 days after ICU admission
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Incidence of acute kidney injury
기간: From ICU admission to ICU discharge
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Occurrence of acute kidney injury during ICU stay
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From ICU admission to ICU discharge
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Vasopressor-free days up to day 28
기간: From ICU admission to day 28
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Number of days alive and free from vasopressor support within the first 28 days after ICU admission
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From ICU admission to day 28
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Mechanical ventilation-free days up to day 28
기간: From ICU admission to day 28
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Number of days alive and free from mechanical ventilation within the first 28 days after ICU admission
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From ICU admission to day 28
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Renal replacement therapy-free days up to day 28
기간: From ICU admission to day 28
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Number of days alive and free from renal replacement therapy within the first 28 days after ICU admission
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From ICU admission to day 28
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ICU length of stay
기간: From ICU admission to day 28
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Length of stay in the intensive care unit
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From ICU admission to day 28
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Hospital length of stay
기간: Through hospital discharge, an average of 28 days
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Total length of hospital stay
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Through hospital discharge, an average of 28 days
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Change in qSOFA score at 24 and 72 hours
기간: Baseline (ICU admission), 24 hours, and 72 hours
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Change in quick Sequential Organ Failure Assessment (qSOFA) score at 24 and 72 hours from ICU admission
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Baseline (ICU admission), 24 hours, and 72 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alvaro Casado Iglesias, MD, Clinica Universidad de Navarra
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
기타 연구 ID 번호
- POCUS-SHOCK
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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