Clinical Trial: Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration
Brief Summary: One of the leading health issues among patients, particularly children, presenting for care in low- and middle-income countries is dehydration. When oral rehydration is not sufficient or is clinically inappropriate, rehydration often occurs intravenously. An alternative to intravenous rehydration is subcutaneous infusion and - with or without hyaluronidase enzyme (or Hylenex) - has been shown in several robust trials in high-income countries to be as effective and even safer than intravenous infusion. In this study in western Kenya, the investigators propose a first-ever randomized controlled trial to evaluate whether hyaluronidase-facilitated subcutaneous infusion can be as effective and safe as IV therapy among moderate-to-severely dehydrated patients in low- and middle-income countries.
Detailed Summary:
Subcutaneous (SC) infusion has been established in high-income countries as a safe and effective alternative to expedite and simplify IV access. , A study from 2003 demonstrated the efficacy of SC hydration in elderly patients, for example. Fluid absorption via the SC method was almost identical to that via the IV method. A recent retrospective study compared SC fluid infusion with IV fluid infusion in children and showed that the SC method makes possible a more timely delivery of parenteral fluid with fewer needlesticks.
Additionally, SC hydration has been shown to be even more effective with the addition of recombinant human hyaluronidase, an enzyme that breaks down hyaluronic acid that makes up the extracellular matrix. , (Note: Hyaluronidase, or Hylenex, is not an investigational drug; it is FDA-approved, regularly used in the U.S., and will be procured for this study through the pharmacy of the Massachusetts General Hospital (Boston, USA).) When hyaluronidase is injected subcutaneously, an area forms where fluids do not have a dense matrix to cross. Flow rates with hyaluronidase-assisted SC (hSC) infusion are nearly five times faster than SC fluid administration alone.8 U.S.-based studies comparing hSC rehydration with standard IV rehydration in children with mild-to-moderate dehydration have demonstrated several benefits of hSC, including time and success of line placement, ease of use, satisfaction, and cost-effectiveness.9, These studies concluded that hSC hydration is a reasonable alternative to IV hydration in resource-rich settings, especially for children with difficult IV access.
While hSC infusion has been shown to be safe, successful, and cost-effective in high-income countries like the United States, there have been no randomized control trials in low-resource settings. The benefits of hSC that have been de
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Time to recovery [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
Original Secondary Outcome: Same as current
Information By: Massachusetts General Hospital
Dates:
Date Received: October 7, 2014
Date Started: October 2014
Date Completion: December 2016
Last Updated: September 21, 2015
Last Verified: September 2015
