- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07569406
Use of Oxiris Filter in Septic Shock Patients Requiring Renal Replacement Therapy: A Retrospective Cohort Study
Impact of Oxiris Filter Use on Mortality and Renal Outcomes in Critically Ill Patients With Septic Shock Requiring Renal Replacement Therapy: A Retrospective Cohort Study
연구 개요
상세 설명
Sepsis and septic shock are leading causes of morbidity and mortality in critically ill patients and are commonly associated with acute kidney injury requiring renal replacement therapy (RRT). Extracorporeal blood purification techniques have been proposed as an adjunctive therapy to modulate the host inflammatory response. The Oxiris filter is a modified AN69-based membrane designed to provide renal support while simultaneously adsorbing endotoxins and cytokines.
This retrospective cohort study aims to assess the impact of Oxiris filter use on clinical outcomes in patients with septic shock requiring RRT. The study will include adult patients admitted to an intensive care unit over a defined study period who required RRT due to acute kidney injury in the context of septic shock.
Patients will be categorized according to the type of hemofilter used (Oxiris versus standard filters). The primary outcome will be mortality within a defined follow-up period. Secondary outcomes will include renal recovery, duration of renal replacement therapy, and length of stay in the intensive care unit.
Statistical analyses will be performed to compare outcomes between groups and adjust for potential confounding factors. Appropriate multivariable models will be used to evaluate the association between Oxiris use and clinical outcomes.
Given the retrospective nature of the study, no interventions will be assigned, and all treatments will have been administered according to routine clinical practice.
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:
- Adult patients (≥18 years old)
- Admission to the intensive care unit
- Diagnosis of septic shock
- Requirement of renal replacement therapy due to acute kidney injury
- Treatment with either Oxiris filter or standard hemofilters
Exclusion Criteria:
- Patients under 18 years of age
- Chronic dialysis prior to ICU admission
- Missing key clinical data
- Patients not meeting criteria for septic shock
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Oxiris Group
Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter.
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Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.
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Standard Filter Group
Patients with septic shock requiring renal replacement therapy treated with standard hemofilters.
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Standard hemofilters used for continuous renal replacement therapy without specific adsorption properties for endotoxins or cytokines.
These filters provide conventional renal support and are used according to routine clinical practice.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
28-day all-cause mortality
기간: Up to 28 days
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All-cause mortality within 28 days from the initiation of renal replacement therapy.
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Up to 28 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ICU length of stay
기간: From ICU admission to ICU discharge, assessed up to 28 days
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Length of stay in the intensive care unit measured in days.
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From ICU admission to ICU discharge, assessed up to 28 days
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Renal recovery
기간: Assessed at hospital discharge, up to 90 days
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Recovery of kidney function defined as independence from renal replacement therapy at discharge.
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Assessed at hospital discharge, up to 90 days
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Duration of renal replacement therapy
기간: From initiation to discontinuation of RRT, assessed up to 28 days
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Total duration of renal replacement therapy during ICU stay, measured in days.
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From initiation to discontinuation of RRT, assessed up to 28 days
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In-hospital mortality
기간: From hospital admission to discharge, assessed up to 90 days
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All-cause mortality during hospital stay.
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From hospital admission to discharge, assessed up to 90 days
|
공동 작업자 및 조사자
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
- OXIRIS
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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