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Role of intestinal motility enhancing drugs in cirrhosis patients who are critically ill and not tolerating feeding

To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis- A Randomized Placebo Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011917
Enrollment
162
Registered
2018-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cirrhosis Health Condition 2: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Metaclopromide group: Metoclopromide will be given 10mg intravenous thrice daily Intervention2: Erythromycin group: Erythromycin will be given intravenous 70mg twice daily Control Inter

Sponsors

Institute of liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients who develop new onset feed intolerance to enteral nutrition

Exclusion criteria

Exclusion criteria: 1) Any patient with current or past surgical abdomen including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery. 2) Patients receiving enteral nutrition through gastrostomy or jejunostomy. 3)Patients in whom, prokinetics are contraindicated or are allergic to the same. 4)Patients who received prokinetic more than one day prior to the start of enteral feeding. 5)Patients with uncontrolled sepsis with DIC. 6)Requirement of two or more vasopressors. 7)Organ failure requiring high inotropic support. 8)Advanced cardiopulmonary disease, with prior history of arrhythmias, structural heart disease. 9)History of traumatic brain injury, raised intracranial pressure, history of myasthenia gravis. 10)Endocronolgic illnesses: Hypothyroidism, hypoparathyroidism 11)Connective tissue diseases (systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosis, amyloidosis). 12)Known case of diabetes with diabetic gastroparesis 13)Pregnancy 14)Patients or concerned family member who fail to give consent for study enrollment 15)Age less than 18 years and more than 70 years.

Design outcomes

Primary

MeasureTime frame
Resolution of feed intolerance at 24 hours with improvement in 3 or more points and initiation of entral feeding.Timepoint: 24 hours

Secondary

MeasureTime frame
Number of patients with Initiation of entral nutrition more than 50%. of recommended nutrition (Kcal/kg body weight/day).Timepoint: 72 hours;Number of patients with resolution of atleast 2 out of 5 symptoms in all the 3 groups.Timepoint: 72 hours;Number of patients with resolution of sepsis, shock, organ failure in all the 3 groups.Timepoint: 7 days;Number of patients without inotropic supports in all the 3 groups.Timepoint: 7 days;Number of patients without Ventilatory support in all the 3 groups.Timepoint: 72 hours;SurvivalTimepoint: 72 hours and 7 days

Countries

India

Contacts

Public ContactDr V Rajan

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026