A Trial of the Arctx Cool Catheter in Acute Pancreatitis
ConditionAcute Pancreatitis (AP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorArctx Medical, Inc.
About this trial
Researchers will compare people who get the ACC Set plus standard of care to people who get standard of care alone. This will show whether adding the ACC Set helps.
Participants will:
Join one of two groups, chosen by chance: the ACC Set plus standard of care, or standard of care alone.
Have the cooling tube in place for up to 3 days, if they are in the ACC Set group.
Have blood tests and pain checks every few hours during their hospital stay. Return for follow-up visits about 7, 14, and 30 days later.
Eligibility criteria
Qualifiers
Temperature >38°C (100.4°F) or <36°C (96.8°F)
Heart rate >90 beats per minute
Respiratory rate >20 breaths per minute or PaCO2 <32 mmHg
White blood cell (WBC) count >12,000/mm³ or <4,000/mm³, or >10% immature (band) forms
Disqualifiers
Serum creatinine >1.5 mg/dL
Current treatment with pancreatic enzyme replacement therapy
Current treatment with hemodialysis or peritoneal dialysis
Active malignancy: a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent with no clinical signs or symptoms of the malignancy for at least five years
Trial design
Treatments tested in this trial
- Treatment
- Control
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov