RECRUITING
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8.4% Sodium Bicarbonate Locks in Intestinal Failure
We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.
Conditions:
🦠 Intestinal Failure 🦠 CRBSI - Catheter Related Bloodstream Infection
🗓️ Study Start (Actual) 1 December 2022
🗓️ Primary Completion (Estimated) January 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 15
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Iowa City, Iowa, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration
    • * Subject is less than 18 years of age at the time of study entry
    • * Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)
Ages Eligible for Study: 1 Year to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 March 2023
  • First Submitted that Met QC Criteria 2 April 2023
  • First Posted 14 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023
I'm interested ...!!