Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of therapeutic paracenteses
研究概览
简要总结
The purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years or older of age
- •Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:
- •liver biopsy, OR
- •history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
- •2 of the following 4 criteria: i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score >13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) >2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
- •At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days
排除标准
- •Language barriers that cannot be surmounted with in-person interpreters
- •Estimated life expectancy < 3 months
- •Pregnancy (self-reported)
- •Unable or unwilling to provide consent
- •History of liver transplant
- •Planned discharge to nursing facility
- •Anuria or serum creatinine > 2.0 mg/dL
- •Uncontrolled hepatic encephalopathy
研究组 & 干预措施
Home-delivered, salt restricted
Meal description: salt-restricted (1500 mg to 2000 mg daily), > 2100 kilocalorie, high protein (>80 g daily) in addition to receiving standard pamphlet receipt
干预措施: Meal delivery (Other)
Dietary Advice
Standard of care, advice on salt-restriction using standard pamphlet receipt
干预措施: Standard pamphlet with Dietary Advice (Other)
结局指标
主要结局
Number of therapeutic paracenteses
时间窗: From date of randomization until 12 weeks
Number of paracenteses
次要结局
- Change in Quality of life(baseline, week 12)
研究者
Elliot B. Tapper
Assistant Professor of Internal Medicine
University of Michigan