AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.
연구 개요
상세 설명
The purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications
Participants will be in the study for the first 7 days of hospitalization. The study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize AKI risk as per routine practice.
If the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge.
The investigators will review the participant's medical record up to one year after surgery.
This study will not include any experimental laboratory tests or experimental medication.
The clinical recommendations will regard the following:
- Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)
- Optimizing volume status (avoidance of volume overload or depletion)
- Optimizing electrolytes and acid-base status
- Optimizing hemodynamics (Mean arterial BP>65mmHg)
- Assessment of kidney function with serum creatinine and/or cystatin C None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.
The investigators plan to compare the results of the current study with those in in the years of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Arizona
-
Scottsdale, Arizona, 미국, 85259
- Mayo Clinic in Arizona
-
-
Florida
-
Jacksonville, Florida, 미국, 32224
- Mayo Clinic in Florida
-
-
Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
Adult patients with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied.
Patients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient.
Exclusion criteria:
Patients on dialysis (hemodialysis or peritoneal dialysis).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Subjects with VAD in place
Adult patients with VAD in place who are admitted to the hospital for acute medical illness.
The investigators will provide clinical recommendations to the subject's primary care provider.
|
The clinical recommendations will regard the following:
None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of AKI in hospitalized VAD patients based on AKIN criteria
기간: The first 7 days of hospitalization
|
The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0
fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT
|
The first 7 days of hospitalization
|
|
Severity of AKI based on AKIN stages (I, II, III) 1
기간: The first 7 days of the hospitalization
|
The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0
fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT
|
The first 7 days of the hospitalization
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of hospital stay
기간: One year after hospitalization
|
The length of hospital stay will be determined from the electronic medical record.
|
One year after hospitalization
|
|
In hospital, 60 day and one-year mortality
기간: One year after enrollment
|
The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization
|
One year after enrollment
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Qi Qian, Mayo Clinic
간행물 및 유용한 링크
유용한 링크
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 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. .
급성 신장 손상에 대한 임상 시험
-
The Second Hospital of Qinhuangdao완전한
-
National Health Service, United KingdomUniversity of Bradford완전한
Clinical Recommendations에 대한 임상 시험
-
Beth Israel Deaconess Medical CenterBrigham and Women's Hospital; Clinical Innovations, LLC모병
-
Centre for Addiction and Mental HealthUniversity Health Network, Toronto완전한
-
University of NottinghamEnhanced Recovery After Surgery Group (part of ESPEN)완전한
-
Swiss Group for Clinical Cancer ResearchImmunophotonics, Inc.모병
-
Assistance Publique - Hôpitaux de ParisMetabolomics platform/UMR 1138 INSERM; INSERM U996아직 모집하지 않음
-
Major Extremity Trauma Research Consortium완전한
-
King Abdulaziz University완전한코로나바이러스감염증-19 : 코로나19 | 코로나19 | 사스 코로나바이러스 2 | 코로나바이러스 | 타액 | 바이러스 부하 | 폴리 메라 제 연쇠 반응 | 구강청결제사우디 아라비아