A Phase 2 interventional study of Cold isotonic fluid and central venous hypothermia catheter in Organ Transplantation From Brain-dead Donors, sponsored by University of Pittsburgh. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.
74 studies on the registry are indexed under Brain Death; 9 are open to participants now.
This study's enrollment of 4 is below the median of 46 across 37 interventional studies indexed under Brain Death.
Browse Brain Death studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter
Other: Cold isotonic fluid and central venous hypothermia catheter
Normothermia will be maintained until organ procurement as per current standard of care
20-30ml/kg of isotonic crystalloid resuscitation fluid will be used for induction. Hypothermia (32-33 degrees C) will be sustained until organ procurement using an FDA approved central venous catheter connected to an external temperature regulating system
Feasibility and safety
Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours
Time frame: From enrollment to organ procurement (average of 24 hours)
Six-month hospital free survival in recipients
Data on recipient survival and allograft function will be collected up to 6 months following transplantation
Time frame: 6 months
Interleukin-6
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Actual no. of organs transplanted
Time frame: At the time of organ procurement
Malondialdehyde
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Death receptor-5
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
lactate
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Urinary isoprostanes
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh