Prospective, Multicenter, Randomized Controlled Trial of the Arctx Cool CatheterTM (ACC) Set in Patients With Acute Pancreatitis "CHILL-AP"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
ACC Set
Received Arctx Cool Catheter
干预措施: Treatment (Device)
Control
Standard of Care - Did not receive Arctx Cool Catheter
干预措施: Control (Other)
结局指标
主要结局
Adverse Events
时间窗: 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.
Time to Oral Food Tolerance Without Organ Failure or SIRS
时间窗: 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.
次要结局
- Time to Oral Food Tolerance(From randomization until oral food tolerance, assessed up to hospital discharge (expected average of 1 to 10 days).)
- Length of Hospital Stay(From hospital admission to discharge (assessed up to approximately 21 days).)
- Conversion to More Severe AP Classification(From randomization through the Day 30 (± 14 days) follow-up visit.)
- Time to Modified Pancreatitis Activity Scoring System (mPASS) Score ≤60(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(From randomization to discharge (assessed up to approximately 21 days))
- Total Morphine Equivalent Dose (MED)(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(14 days (± 7 days) following randomization.)
- Total SIRS Duration(From randomization to discharge (assessed up to approximately 21 days).)
- Change in C-Reactive Protein (CRP)(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(From randomization to discharge (assessed up to approximately 21 days).)
- Duration of Organ Failure(From randomization to discharge (assessed up to approximately 21 days).)
- Duration of Fever(From randomization to Primary Endpoint (Anticipated range 1 to 10 days))
- Rehospitalization for Acute Pancreatitis(From hospital discharge through the Day 30 (± 14 days) follow-up visit.)
- Length of ICU Stay(Reported at hospital discharge; measures total ICU stay during the hospitalization (up to approximately 21 days), when applicable.)
- Mortality(From randomization to discharge (assessed up to approximately 21 days))
- Physician / User Satisfaction (ACC Arm Only)(At the time the participant achieves oral food tolerance without organ failure or SIRS, up to approximately 10 days after randomization (device arm only).)