KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure

Conditions

• Pediatric Intestinal Failure

Eligibility Criteria

Sex

ALL

Age

4 Weeks - 18 Years

Healthy Volunteers

Not accepted

Interventions

• KiteLock 4% Sterile Catheter Lock Solution — DEVICE
  KiteLock™ is a clear, colorless, and sterile 4% (40 mg/ml) tetrasodium EDTA solution that contains no preservatives, latex, antibiotics, or ethanol and is nonpyrogenic. Tetrasodium salt of EDTA has been shown to disrupt in vivo and ex vivo-generated biofilms by destabilizing the structural integrity of micro-organisms at the cellular level.
• Heparin Lock Solution — DEVICE
  Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.

Study Details

A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).

Key Dates

Start date

Jun 21, 2024

Status verified

Jun 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

124 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: KiteLock 4% Sterile Catheter Lock Solution
  4% Tetrasodium EDTA lock solution (KiteLock 4% Sterile Catheter Lock Solution; SterileCare Inc., Canada) will be administered 4-24 hours daily while the patient is cycled off their PN, as per site standard operating procedures.
• Active Comparator: Heparin Lock Solution
  Heparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects.

Primary Outcome Measure

Incidence of catheter occlusions [ Time Frame: 52 weeks ]

Central Contacts

• Joanne Greco
  6472006232
  [email protected]

Locations (8)

Find similar trials in Boston, MA

Related Studies

• Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure
  Recruiting · Boston Children's Hospital · Birmingham, Alabama