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CompletedNCT02528760Updated Nov 21, 2017

To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis

An interventional study of Metaclopramide and Erythromycin in Cirrhosis, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

  1. All patients with chronic liver disease admitted in ICU (Intensive Care Unit) to be screened.
  2. Patients fulfilling criteria for feed intolerance to be included in the study.
  3. Patients to undergo routine biochemical and hematological testing including CBC, KFT, LFT, PT/INR, electrolytes baseline and daily along with ABG (Arterial Blood gas) analysis.
  4. Patients with ascites to be tested for presence or absence of SBP (Spontaneous Bacterial Peritonitis).
  5. Cultures to be sent as based on clinical parameter of the patient.
  6. All correctable causes for intra abdominal hypertension to be corrected including electrolyte imbalance, grade III ascites, intra abdominal infection.
  7. Symptoms- Absent bowel sounds (BS)= no BS detected by auscultation. Vomiting/regurgitation= any visible regurgitation of gastric contents; Diarrhoea= liquid stool > or =3 times/day; Bowel distension= suspected clinically and radiologically confirmed; Large gastric residual volume (GRV) of >or =500 ml/24 h on a single day or > 200ml at any time of the day.
  8. Per abdomen findings to be checked daily including presence of bowel sounds, tenderness, development of abdominal distension, abdominal girth monitoring and abdominal pressure monitoring.
  9. Patients who develop feed intolerance will be included.
  10. Feed intolerance to be defined as per study definition (3 out of 5 symptoms).
  11. Measurement of GRV (Gastric residual volume) to be done at 4 hourly interval.
  12. Methods for measuring GRV by either gravity drainage by connecting a gastric tube to a drainage bag for 10min or by manual aspiration of content using a 50ml syringe.
  13. Once feed intolerance develop than every 6 hourly intra abdominal pressure monitoring and abdominal girth monitoring to be done (24)
  14. Intra bladder pressure to be measured using Foleys manometer technique (25).
  15. Pressure measured in cm of water to be converted into mm of Hg.
  16. X ray abdomen supine to look for bowel distension, defined as more than 3 cm for small bowel and more than 5 cm in large bowel.
  17. Development of intra abdominal hypertension based on intra abdominal pressure.
  18. Patient to be stratified according to the grade of intra-abdominal hypertension.
  19. After correction of all correctable causes, if feed intolerance persists, then patient to be randomized by block randomization method into 3 arms, metaclopromide group, erythromycin group or placebo group.
  20. Daily assessment of bowel sounds, abdominal pressure, abdominal girth every 6 hourly and gastric residual volume to be noted every 4 hourly.
  21. Response of therapy to be assessed at 24 hours in each arm.
  22. Response to be assessed by resolution of feed intolerance or initiation of entral nutrition.
  23. Metoclopromide to be given 10mg iv 8 hourly.
  24. Erythromycin to be given 70mg iv 12 hourly (26).
  25. Placebo arm to receive normal saline in 10ml syring twice daily.
  26. After 24 hours of treatment if symptoms do not resolve than rescue treatment will be given to each arm which may include continuation of prokinetics, add on prokinetic, flatus tube insertion for bowel decompression, upgradation of antibiotics or search for any other cause, as per the patient response.
  27. Therapy to continue for a total duration of 72 hours.
  28. If there is no response at 72 hours, than study stops.
  29. If patient responds to given treatment, study to continue for a total duration of 7 days.
  30. Assessment to continue in each arm for a maximum period of 7 days.
02

Conditions studied

  • Cirrhosis
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 83 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    Metaclopromide group

    Drug: Metaclopramide

  • Experimental
    Erythromycin group

    Drug: Erythromycin

  • Placebo comparator
    Placebo group

    Other: Placebo

Interventions

  • DrugMetaclopramide

    23. Metoclopromide to be given 10mg iv 8 hourly

  • DrugErythromycin

    Erythromycin to be given 70mg iv 12 hourly.

  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Resolution of feed intolerance at 24 hours with improvement in 3 or more points and initiation of entral feeding.

    Feed intolerance to be defined as 3/5 symptoms which include gastric residual volume \> 500 ml /day,absence of bowel sounds,vomitting/regurgitation,diarrhoea and bowel distension

    Time frame: 24 hours

Secondary outcomes

  1. Survival

    Time frame: 72 hours

  2. Survival

    Time frame: 7 days

  3. Number of patients with Initiation of entral nutrition more than 50%. of recommended nutrition (Kcal/kg body weight/day).

    Feed intolerance is also defined when entral nutrition provided \< 20Kcal/kg body weight/day.

    Time frame: 72 hours

  4. Number of patients with resolution of atleast 2 out of 5 symptoms in all the 3 groups.

    Feed intolerance to be defined as 3/5 symptoms which include gastric residual volume \> 500 ml /day,absence of bowel sounds,vomitting/regurgitation,diarrhoea and bowel distension

    Time frame: 72 hours

  5. Number of patients with resolution of sepsis, shock, organ failure in all the 3 groups.

    Time frame: 7 days

  6. Number of patients without Ventilatory support in all the 3 groups.

    Time frame: 7 days

  7. Number of patients without inotropic supports in all the 3 groups.

    Time frame: 7 days

07

Study locations

1 site
  • Institute of liver and Biliary Sciences
    New Delhi, Delhi 110070, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02528760
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Aug 19, 2015
Start date
Sep 24, 2015
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017
Last update
Nov 21, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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