A Trial of the Arctx Cool Catheter in Acute Pancreatitis (CHILL-AP)
Prospective, Multicenter, Randomized Controlled Trial of the Arctx Cool CatheterTM (ACC) Set in Patients With Acute Pancreatitis "CHILL-AP"
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
CHILL-AP is a prospective, multicenter, randomized controlled trial evaluating the safety and effectiveness of the Arctx Cool Catheter (ACC) Set in patients hospitalized with acute pancreatitis (AP). The study is designed to support a marketing submission to the U.S. Food and Drug Administration (FDA).
Background and rationale: There are currently no FDA-approved therapies for AP; care is supportive and consists of fluid replacement, nutrition support, and pain control. In AP, the body's inflammatory response can become severe and progress to systemic inflammatory response syndrome (SIRS) and organ failure. Laboratory and early clinical evidence suggests that cooling the pancreas can calm this early inflammation, regardless of what caused the AP. The ACC Set is intended to cool the pancreas locally, without cooling the whole body, in order to reduce the severity of AP and shorten the time it takes to recover.
Investigational device: The ACC Set is made up of the Arctx Catheter and an Arctx Extension Line that connects the catheter to a Blanketrol III Hyper-Hypothermia System. The Arctx Catheter is a single-use, non-implantable tube with several channels, placed in the stomach/duodenum. Two channels circulate the cooling fluid through the connected heat exchanger; a third channel allows fluids to be given or drained through the gut.
Design and randomization: Eligible participants are randomized 1:1, stratified by site, to receive either the ACC Set plus standard of care or standard of care alone. The study may enroll up to 200 participants (approximately 100 per arm) at up to 25 sites in the United States and Latin America, with at least 50% of participants enrolled at U.S. sites and no single site enrolling more than 20% of total enrollment. Bias is minimized through randomization, objective eligibility criteria, uniform effectiveness criteria, an independent blinded image reviewer, and oversight by an independent Data Monitoring Committee (DMC).
Intervention: For participants randomized to the device arm, ACC placement and the start of cooling must occur within a total of 48 hours of symptom onset. Eligibility is reconfirmed immediately before placement. The device may remain in place for up to 72 hours, with earlier removal at the investigator's discretion; if a device is removed and replaced, the total time in use may not exceed 72 hours. An x-ray taken after placement confirms the position. Body temperature and gut (catheter) temperature are monitored during cooling. The gut is examined with an endoscope when there is a clinical reason to do so.
Standard of care and nutrition: Initial management in both arms follows American Gastroenterological Association Institute guidance, with medications given per each institution's standard of care. To support consistent assessment of the primary endpoint, feeding and the measurement of food tolerance are standardized across sites and across both arms. Standardized oral nutrition of at least 500 calories is offered, and the percentage of calories eaten, abdominal pain, and any vomiting are recorded around each feeding.
Assessments and follow-up: After randomization, nutrition intake is assessed about every 6 hours with standard mealtimes, and blood tests (CBC, CMP including amylase and lipase, and C-reactive protein) along with PASS and mPASS scoring are obtained about every 12 hours, each continuing until the participant can tolerate oral food without organ failure or SIRS. A contrast-enhanced CT is obtained at baseline and at Day 14.
Follow-up visits occur at Day 7, Day 14, and Day 30, with the Day 30 visit occurring 30 days after hospital discharge. An independent radiologist experienced in AP reviews the baseline and Day 14 contrast-enhanced CTs.
Statistical considerations: The primary effectiveness analysis is performed on the intent-to-treat (ITT) population, with sensitivity analyses on the modified ITT and per-protocol populations; safety is analyzed on all treated participants. The effectiveness sample size of 188 participants (94 per group) provides 80% power at a one-sided alpha of 0.025 to detect the expected difference in time to oral food tolerance, assuming a 5% dropout rate; the total of 200 participants also meets the goal of about 100 participants in the treatment arm for safety.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Cindy Grabowski
- Telefonní číslo: 6122453733
- E-mail: cgrabowski@arctxmedical.com
Studijní záloha kontaktů
- Jméno: Cassie Frye
- E-mail: cfrye@arctxmedical.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Meets criteria for SIRS, defined as meeting two of the following four criteria, which need not be present simultaneously and may be demonstrated at any point during the screening-to-randomization window:
- 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
- Symptom onset within a window of time enabling ACC placement within a total of 48 hours
- Diagnosis of acute pancreatitis by all three of the following criteria at the time of presentation (not referred), significant enough to require hospitalization:
- Abdominal pain consistent with acute pancreatitis (acute onset of persistent, severe, epigastric pain, often radiating to the back)
- Serum amylase and/or lipase greater than 3 times the upper limit of normal
- Characteristic findings on contrast-enhanced CT (CECT). Note: If CT is not standard of care, it will be performed after the patient signs informed consent and all other eligibility criteria are met.
- Signed written informed consent, and willingness and ability to complete follow-up requirements
Exclusion Criteria:
- Serum creatinine >1.5 mg/dL or Glomerular filtration rate (GFR) < 30
- Current treatment with pancreatic enzyme replacement therapy
- Current treatment with hemodialysis or peritoneal dialysis
- Treatment for all non-basal cell cancer within the last 1 year
- Pancreatic calcifications identified by the baseline contrast-enhanced CT (CECT)
- Receiving anti-coagulation or platelet count less than 50,000
- Known history of chronic pancreatitis
- Surgery or endoscopic procedure for drainage or evidence of any pancreatic or gastrointestinal surgery (including gastric bypass)
- Recurrent acute pancreatitis within 30 days
- Suspected inability or contraindication to pass a naso-gastric catheter
- Less than 40 kg of body mass
- Known allergy to any device component (polyurethane, barium sulphate, polyvinyl chloride, polycarbonate, nylon, ABS, polyethylene)
- Female who is pregnant
- Participated in another investigational drug or therapeutic medical device study within 30 days before randomization
- Any history of congestive heart failure
- History of peptic ulcer disease and/or H. pylori within the past year
- Body mass index ≥40 kg/m², or BMI ≥35 kg/m² with significant comorbidity, as determined at the investigator's discretion
- Currently using GLP-1 receptor agonists (RAs)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: ACC Set
Received Arctx Cool Catheter
|
Participants in the treatment arm receive standard of care for acute pancreatitis plus the Arctx Cool Catheter (ACC) Set.
Standard of care follows American Gastroenterological Association Institute guidance and includes fluid resuscitation, nutrition support, and pain management, with medications given per each institution's standard of care.
In addition, the ACC Set is placed and regional pancreatic cooling is started within a total of 48 hours of symptom onset, and the device remains in place for up to 72 hours, with earlier removal at the investigator's discretion.
Feeding and the measurement of food tolerance are standardized across both arms, so treatment participants receive the same standardized oral nutrition and the same nutrition, pain, and blood-test assessment schedule as the control arm.
Ostatní jména:
|
|
Aktivní komparátor: Control
Standard of Care - Did not receive Arctx Cool Catheter
|
Participants in the control arm receive standard of care for acute pancreatitis without the ACC Set.
Initial management follows American Gastroenterological Association Institute guidance and includes fluid resuscitation, nutrition support, and pain management, with medications given per each institution's standard of care.
Feeding and the measurement of food tolerance are standardized across both arms, so control participants receive the same standardized oral nutrition and the same nutrition, pain, and blood-test assessment schedule as the treatment arm.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adverse Events
Časové okno: From randomization through the Day 30 (± 14 days) follow-up visit following hospital discharge.
|
All adverse events are evaluated by seriousness, severity, relatedness to the device, and relatedness to the procedure.
Events that are both serious and device-related are also assessed for whether they were anticipated.
Adverse events in the ACC Set arm are compared to the control arm to identify any increased risk associated with device use.
|
From randomization through the Day 30 (± 14 days) follow-up visit following hospital discharge.
|
|
Time to Oral Food Tolerance Without Organ Failure or SIRS
Časové okno: From randomization until oral food tolerance without organ failure or SIRS, assessed up to hospital discharge (Expected average 1 to 10 days).
|
The number of hours from randomization to the time the participant tolerates oral food without organ failure or systemic inflammatory response syndrome (SIRS).
Tolerating oral food is defined as eating at least 50% of a low-fat meal of at least 500 calories without an increase in abdominal pain or vomiting.
Organ failure is defined by the Modified Marshall scoring system (a score of 2 or more in any organ system).
SIRS is defined as meeting two or more of four criteria: Heart rate >90 beats/min, Core temperature <36°C or >38°C, White blood count <4000 or >12000 cells/mm3 or >10% Immature (band) forms, Respirations >20 breaths/min or PaCO2 <32 mmHg.
|
From randomization until oral food tolerance without organ failure or SIRS, assessed up to hospital discharge (Expected average 1 to 10 days).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Oral Food Tolerance
Časové okno: From randomization until oral food tolerance, assessed up to hospital discharge (expected average of 1 to 10 days).
|
The number of hours from randomization to the time the participant tolerates oral food, defined as eating at least 50% of a low-fat meal of at least 500 calories without an increase in abdominal pain or vomiting.
(This endpoint measures food tolerance alone, without the organ failure / SIRS requirement of the primary effectiveness endpoint.)
|
From randomization until oral food tolerance, assessed up to hospital discharge (expected average of 1 to 10 days).
|
|
Length of Hospital Stay
Časové okno: From hospital admission to discharge (assessed up to approximately 21 days).
|
Length of hospital stay measured from the date of admission to the date of discharge.
|
From hospital admission to discharge (assessed up to approximately 21 days).
|
|
Conversion to More Severe AP Classification
Časové okno: From randomization through the Day 30 (± 14 days) follow-up visit.
|
The percentage of participants who convert to a more severe acute pancreatitis classification, as measured by the Revised Atlanta Classification (mild, moderately severe, or severe), from randomization to discharge.
|
From randomization through the Day 30 (± 14 days) follow-up visit.
|
|
Time to Modified Pancreatitis Activity Scoring System (mPASS) Score ≤60
Časové okno: From randomization until mPASS ≤60, assessed up to hospital discharge (assessed up to approximately 21 days).
|
The time from randomization to achievement of Modified Pancreatitis Activity Scoring System (mPASS Score) score of 60 or less. The mPASS score is calculated from the Pancreatitis Activity Scoring System (PASS) score by removing the morphine equivalent dose (MED) component. The theoretical minimum score is 0 and the maximum score does not have a strict cap, but typical scores range into the hundreds, with higher scores indicating greater disease activity. The Modified Pancreatitis Activity Scoring System (mPASS) includes four dynamic variables:
|
From randomization until mPASS ≤60, assessed up to hospital discharge (assessed up to approximately 21 days).
|
|
Time to Pancreatitis Activity Scoring System (PASS) Score ≤60
Časové okno: From randomization to discharge (assessed up to approximately 21 days)
|
The time from randomization to achievement of Pancreatitis Activity Scoring System (PASS Score) score of 60 or less. The theoretical minimum score is 0 and the maximum score does not have a strict cap, but typical scores range into the hundreds, with higher scores indicating greater disease activity. Pancreatitis Activity Scoring System (PASS) includes five dynamic variables:
|
From randomization to discharge (assessed up to approximately 21 days)
|
|
Total Morphine Equivalent Dose (MED)
Časové okno: From randomization until oral food tolerance without organ failure or SIRS. (Expected range 1 to 10 days)
|
Total morphine equivalent dose administered from randomization until oral food
|
From randomization until oral food tolerance without organ failure or SIRS. (Expected range 1 to 10 days)
|
|
Severity of Acute Pancreatitis by Modified CT Severity Index (mCTSI) at Day 14
Časové okno: 14 days (± 7 days) following randomization.
|
Severity of acute pancreatitis measured by the Modified Computed Tomography Severity Index (mCTSI) score, calculated using the standard definition from the Day 14 contrast-enhanced CT, as read by an independent radiologist.
The Modified CT Severity Index (mCTSI) ranges from 0 to 10, with higher scores indicating greater disease severity.
|
14 days (± 7 days) following randomization.
|
|
Total SIRS Duration
Časové okno: From randomization to discharge (assessed up to approximately 21 days).
|
Total duration of systemic inflammatory response syndrome (SIRS) between randomization and discharge.
SIRS is defined by having two or more of the following four criteria: Heart rate >90 beats/min, Core temperature <36°C or >38°C, White blood count <4000 or >12000/mm3 or >10% Immature (band) forms, Respirations >20/min or PCO2 <32 mmHg.
|
From randomization to discharge (assessed up to approximately 21 days).
|
|
Change in C-Reactive Protein (CRP)
Časové okno: From randomization until oral food tolerance without organ failure or SIRS, assessed up to hospital discharge (expected range 1 to 10 days).
|
Change in C-reactive protein, an inflammation marker measured by blood test, from randomization to disease resolution (oral food tolerance without organ failure or SIRS).
|
From randomization until oral food tolerance without organ failure or SIRS, assessed up to hospital discharge (expected range 1 to 10 days).
|
|
Incidence of Organ Failure
Časové okno: From randomization to discharge (assessed up to approximately 21 days).
|
The proportion of participants experiencing organ failure from randomization to discharge.
Organ failure is defined using the Modified Marshall Scoring System, which scores three organ systems (respiratory, renal, and cardiovascular) individually from 0 to 4, with higher scores indicating greater dysfunction.
Organ failure is defined as a score of 2 or more in any single organ system.
|
From randomization to discharge (assessed up to approximately 21 days).
|
|
Duration of Organ Failure
Časové okno: From randomization to discharge (assessed up to approximately 21 days).
|
Duration of organ failure from randomization to discharge.
Organ failure is defined using the Modified Marshall Scoring System, which scores three organ systems (respiratory, renal, and cardiovascular) individually from 0 to 4, with higher scores indicating greater dysfunction.
Organ failure is defined as a score of 2 or more in any single organ system.
|
From randomization to discharge (assessed up to approximately 21 days).
|
|
Duration of Fever
Časové okno: From randomization to Primary Endpoint (Anticipated range 1 to 10 days)
|
Duration of fever from randomization until oral food tolerance without organ failure or SIRS.
|
From randomization to Primary Endpoint (Anticipated range 1 to 10 days)
|
|
Rehospitalization for Acute Pancreatitis
Časové okno: From hospital discharge through the Day 30 (± 14 days) follow-up visit.
|
The proportion of participants rehospitalized for acute pancreatitis from initial hospital discharge through the 30 day follow-up visit.
|
From hospital discharge through the Day 30 (± 14 days) follow-up visit.
|
|
Length of ICU Stay
Časové okno: Reported at hospital discharge; measures total ICU stay during the hospitalization (up to approximately 21 days), when applicable.
|
Length of intensive care unit (ICU) stay, when applicable.
|
Reported at hospital discharge; measures total ICU stay during the hospitalization (up to approximately 21 days), when applicable.
|
|
Mortality
Časové okno: From randomization to discharge (assessed up to approximately 21 days)
|
All-cause mortality from randomization to discharge.
|
From randomization to discharge (assessed up to approximately 21 days)
|
|
Physician / User Satisfaction (ACC Arm Only)
Časové okno: At the time the participant achieves oral food tolerance without organ failure or SIRS, up to approximately 10 days after randomization (device arm only).
|
Physician/user satisfaction is assessed via a study-specific questionnaire covering ease of ACC placement and removal, perceived participant benefit, and any Blanketrol disconnection during the cooling cycle.
Each item is rated on its own categorical response scale (e.g., Very easy to Very difficult; Significant benefit to No benefit) with space for free-text comments; no composite numeric score is calculated.
|
At the time the participant achieves oral food tolerance without organ failure or SIRS, up to approximately 10 days after randomization (device arm only).
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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