Friday, June 19, 2015

Direct Peritoneal Resuscitation (DPR) for Organ Donors



Clinical Trial Protocol (May Be Used Off-Protocol)
Clinical Study Brief Description:  Subjects and Groupings:  Our study will focus on 306 patients who have suffered brain death and have been consented for organ donation via regional organ procurement organization policy.  These patients will then be randomized into four study arms patient arms based on cause of race, gender, age, blood type, cause of death, smoking status, presence of hypertension, presence of hepatitis, and serum creatinine > 1.5 at the time of consent.   Number and grouping of subjects is shown in figure 16.  Patient exclusion criteria (for the clinical trial, not necessarily in practical use) will be: 1) age less than 18 years, 2) patient with previous abdominal surgery to the extent that placement of DPR catheter would represent an unacceptable risk to organ retrieval, 3) patients donating after cardiac death, 4) Hemodynamic instability following brain death to the extent that subjects are expected to need urgent organ procurement within 8 hours of consent, 5) patients whose geographic location precludes the expeditious placement of a DPL catheter within 6 hours of donation consent.
Clinical Protocol:
1.     Identify potential donor candidate for study (see exclusion criteria)
2.     Obtain donation consent via usual OPO process
3.     Utilize study website for randomization protocol (4 groups, 2 randomized to control and 2 to DPR)
4.     Draw Time 0 blood specimen (2 red top tubes)
5.     Surgeon to place DPL catheter using Bard DPL catheter kit (provided)
6.     Technique: Briefly, under sterile technique at the bedside, an infra umbilical incision will be made in the skin in order to directly visualized the abdominal wall fascia. The fascia will be incised and under direct visualization a catheter will be placed into the peritoneal cavity and directed towards the pelvis.  The skin will be closed around the catheter and sterile dressing applied. 
7.     Initiate DPR solution Delflex 2.5% (3 liter bag) – instill 1 liter over an hour, let that liter dwell in patient for an hour, and then allow gravity to empty patient for an hour (total 3 hour cycle).  Repeat this process though the first 9-12 hours of donor management (usually 1-2 bags of Delflex 2.5% PD solution).
8.     Draw Time 3 hours blood specimen (2 red top tubes) – 3 hours post initiation of DPR
9.     Draw Time 6 hours blood specimen (2 red top tubes) – 6 hours post initiation of DPR
10.   Draw Time 12 hours blood specimen (2 red top tubes) – 12 hours post initiation of DPR
11.   Draw Procurement blood specimen (2 red top tubes) – just prior to going to or in OR for recovery
12.   DPR catheter may be removed prior to recovery (just remove stitch and pull out)
13.   All ten blood tubes will be labelled with preprinted labels (provided) and mailed to our site laboratory on dry ice following recovery (or next morning depending on availability of UPS services (mailers will be provided to study sites)
14.   Complete paperwork in DonorNet as per your usual process

Donor management will occur by the usual OPO process and all documentation will follow the usual OPO process.  The principle study site (University of Louisville) and KODA will provide personnel to coordinate the retrieval of electronic data from DonorNet.  Each OPO will manage their own portion of the grant funds via contract and distribute physician/personnel payment as they see fit.  Supply charges are built into the grant budget.