Hypothermic Kidney Machine Perfusion With Omnisol (OMNIPUMP)
A Single-Center, Non-Randomized Safety Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function.
Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.
연구 개요
상태
상세 설명
Hypothermic machine perfusion (HMP) is increasingly used for the preservation of deceased donor kidneys before transplantation. Omnisol was developed as an extracellular-type organ preservation solution for the flushing and HMP of donor kidneys.
Omnisol organ preservation solution was developed to improve kidney transplant outcomes. It is an extracellular-type solution containing the synthetic colloid polyethylene glycol (PEG) and several impermeants for optimal osmotic pressure. It further contains multiple buffering agents for the prevention of intracellular acidosis, antioxidants for the minimization of ROS-induced injury and amino acids and other substrates for supporting the cell metabolism during hypothermic machine perfusion (HMP) as well as the provision of substrates for regeneration of high-energy phosphate compounds during graft reperfusion.
This prospective, single-center, non-randomized clinical investigation is designed primarily to evaluate the safety of Omnisol when used for the wash-out and HMP of kidneys from deceased donors before transplantation. The investigation incorporates a retrospective matched-control design, where each recipient of a kidney preserved with Omnisol will be matched with two recipients previously transplanted at the same center with kidneys preserved by HMP using UW-MPS.
This study employs a back-to-base design, meaning that after arrival at the transplant center according to standard of care, the kidney is flushed with Omnisol and transferred to HMP using Omnisol in the standard of care perfusion machine until implantation.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Inclusion for donor:
- Donor age > 18 years
- Brain Death (DBD) or Circulatory Death (DCD)
- Accepted for transplantation according to local criteria
- For DCD donors: functional warm ischemia time (WIT) ≤ 30 minutes and total WIT ≤ 60 minutes
- Cold ischemia time (CIT) prior to HMP with Omnisol no greater than 14 hours
Inclusion for recipient:
- Male or female, age > 18 years
- Able and willing to provide informed consent and comply with all study requirements (in opinion of investigator or deputy)
- General inclusion criteria applicable to kidney transplantation:
- Listed for renal transplantation due to end stage renal disease on OPO list
- Able and willing to comply with all study requirements (in opinion of investigator or deputy)
- Fit to proceed with kidney
Exclusion Criteria:
Exclusion for donor:
• Donor kidneys accepted as a pair for dual transplant
Exclusion for recipient:
- General exclusion criteria applicable to kidney transplantation
- Breast-feeding or pregnant, as confirmed by pregnancy test or blood test, or plans to become pregnant over the study period
- Participation in an investigational study likely to affect interpretation of the trial data
- Mental disabilities that may affect the understanding of the study requirements including the ability to adhere to medication regime (in opinion of investigator or deputy)
- Undergoing living donor kidney transplantation
- Undergoing dual kidney transplantation
- Undergoing transplantation of other organ(s) in addition to the kidney
- Highly sensitized patients with cPRA > 80% (based on routine HLA antibody assessment)
- Positive donor-specific crossmatch, if performed per institutional standard practice
- Other substantial risk of transplant not proceeding (in opinion of investigator or deputy)
- Other significant disease or disorder which, in the opinion of the Investigator, may: (i) put the participant at risk by participating in the study; (ii) influence the result of the study; (iii) affect the participant's ability to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Donation after brain death (DBD)
Recipients of a kidney from a donor after brain death (DBD). After arrival at the transplant center according to standard of care, kidneys will be flushed with Omnisol and placed on the standard of care HMP machine for perfusion with Omnisol until transplantation. |
Omnisol for HMP of DBD or DCD donors. |
|
실험적: Donation after circulatory death (DCD)
Recipients of a kidney from a donor after circulatory death (DCD). After arrival at the transplant center according to standard of care, kidneys will be flushed with Omnisol and placed on the standard of care HMP machine for perfusion with Omnisol until transplantation. |
Omnisol for HMP of DBD or DCD donors. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Delayed Graft Function
기간: 7 days post-transplantation.
|
Incidence of delayed graft function, defined as the requirement for at least one dialysis session within the first 7 days after transplantation, excluding a single dialysis session performed solely for hyperkalemia or volume overload. |
7 days post-transplantation.
|
|
Graft Survival
기간: 30 days post-transplantation.
|
30-day graft survival, censored and uncensored for recipient death. |
30 days post-transplantation.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Graft Survival
기간: 3, 6 and 12 months post-transplantation.
|
Graft survival, censored and uncensored for recipient death. |
3, 6 and 12 months post-transplantation.
|
|
Recipient Survival
기간: 30 days, 3, 6 and 12 months post-transplantation.
|
Rate of recipient survival. |
30 days, 3, 6 and 12 months post-transplantation.
|
|
Kidney Graft Function
기간: 30 days, 3, 6 and 12 months post-transplantation.
|
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI creatinine equation. |
30 days, 3, 6 and 12 months post-transplantation.
|
|
Primary Non-Function
기간: 30 days, 3, 6 and 12 months post-transplantation.
|
Incidence of irreversible graft failure with no initial evidence of graft function following transplantation. |
30 days, 3, 6 and 12 months post-transplantation.
|
|
Duration of Delayed Graft Function
기간: 30 days post-transplantation.
|
Duration of delayed graft function in participants who require renal replacement therapy after kidney transplantation. |
30 days post-transplantation.
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OMNISOL_HMP_US
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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