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

November 18, 2017 updated by: Institute of Liver and Biliary Sciences, India

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

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Patients who develop new onset feed intolerance to enteral nutrition

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group
Other: Placebo
Experimental: Metaclopromide group
Drug: Metaclopramide
23. Metoclopromide to be given 10mg iv 8 hourly
Experimental: Erythromycin group
Drug: Erythromycin
Erythromycin to be given 70mg iv 12 hourly.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resolution of feed intolerance at 24 hours with improvement in 3 or more points and initiation of entral feeding.
Time Frame: 24 hours
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
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 72 hours
72 hours
Survival
Time Frame: 7 days
7 days
Number of patients with Initiation of entral nutrition more than 50%. of recommended nutrition (Kcal/kg body weight/day).
Time Frame: 72 hours
Feed intolerance is also defined when entral nutrition provided < 20Kcal/kg body weight/day.
72 hours
Number of patients with resolution of atleast 2 out of 5 symptoms in all the 3 groups.
Time Frame: 72 hours
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
72 hours
Number of patients with resolution of sepsis, shock, organ failure in all the 3 groups.
Time Frame: 7 days
7 days
Number of patients without Ventilatory support in all the 3 groups.
Time Frame: 7 days
7 days
Number of patients without inotropic supports in all the 3 groups.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILBS-Cirrhosis-005

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