CirrhosisNCT02528760
To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis
A study testing Metaclopramide and Erythromycin in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Metaclopramide and Erythromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteIndia
- Study dates
- 24 Sep 2015to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients who develop new onset feed intolerance to enteral nutrition
Who cannot join
- Any patient with current or past surgical abdomen including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery.
- Patients receiving enteral nutrition through gastrostomy or jejunostomy.
- Patients in whom, prokinetics are contraindicated or are allergic to the same.
- Patients who received prokinetic more than one day prior to the start of enteral feeding.
- Patients with uncontrolled sepsis with DIC.
- Requirement of two or more vasopressors.
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- Organ failure requiring high inotropic support.
- Advanced cardiopulmonary disease, with prior history of arrhythmias, structural heart disease.
- History of traumatic brain injury, raised intracranial pressure, history of myasthenia gravis.
- Endocronolgic illnesses: Hypothyroidism, hypoparathyroidism
- Connective tissue diseases (systemic sclerosis, dermatomyositis or polymyositis, systemic lupus erythematosis, amyloidosis).
- Known case of diabetes with diabetic gastroparesis
- Pregnancy
- Patients or concerned family member who fail to give consent for study enrollment
- Age less than 18 years and more than 70 years.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis- A Randomized Placebo Controlled Study
- All patients with chronic liver disease admitted in ICU (Intensive Care Unit) to be screened.
- Patients fulfilling criteria for feed intolerance to be included in the study.
- 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.
- Patients with ascites to be tested for presence or absence of SBP (Spontaneous Bacterial Peritonitis).
- Cultures to be sent as based on clinical parameter of the patient.
- All correctable causes for intra abdominal hypertension to be corrected including electrolyte imbalance, grade III ascites, intra abdominal infection.
- 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.
- Per abdomen findings to be checked daily including presence of bowel sounds, tenderness, development of abdominal distension, abdominal girth monitoring and abdominal pressure monitoring.
- Patients who develop feed intolerance will be included.
- Feed intolerance to be defined as per study definition (3 out of 5 symptoms).
- Measurement of GRV (Gastric residual volume) to be done at 4 hourly interval.
- 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.
- Once feed intolerance develop than every 6 hourly intra abdominal pressure monitoring and abdominal girth monitoring to be done (24)
- Intra bladder pressure to be measured using Foleys manometer technique (25).
- Pressure measured in cm of water to be converted into mm of Hg.
- 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.
- Development of intra abdominal hypertension based on intra abdominal pressure.
- Patient to be stratified according to the grade of intra-abdominal hypertension.
- 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.
- Daily assessment of bowel sounds, abdominal pressure, abdominal girth every 6 hourly and gastric residual volume to be noted every 4 hourly.
- Response of therapy to be assessed at 24 hours in each arm.
- Response to be assessed by resolution of feed intolerance or initiation of entral nutrition.
- Metoclopromide to be given 10mg iv 8 hourly.
- Erythromycin to be given 70mg iv 12 hourly (26).
- Placebo arm to receive normal saline in 10ml syring twice daily.
- 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.
- Therapy to continue for a total duration of 72 hours.
- If there is no response at 72 hours, than study stops.
- If patient responds to given treatment, study to continue for a total duration of 7 days.
- Assessment to continue in each arm for a maximum period of 7 days.
- Conditions
- Cirrhosis
- Being tested
- Metaclopramide, Erythromycin, Placebo
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaclopramideDrug
- Metoclopromide to be given 10mg iv 8 hourly
ErythromycinDrug
Erythromycin to be given 70mg iv 12 hourly.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Metaclopromide group | Experimental | Not described Receives: Drug: Metaclopramide |
| Erythromycin group | Experimental | Not described Receives: Drug: Erythromycin |
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (7)
Survival
Measured: 72 hours
Survival
Measured: 7 days
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.
Measured: 72 hours
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
Measured: 72 hours
Number of patients with resolution of sepsis, shock, organ failure in all the 3 groups.
Measured: 7 days
Number of patients without Ventilatory support in all the 3 groups.
Measured: 7 days
Number of patients without inotropic supports in all the 3 groups.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start24 Sep 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528760
- Sponsor's protocol ID
- ILBS-Cirrhosis-005
- Status last verified
- Sep 2016
- First submitted
- 17 Aug 2015
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis- A Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02528760
- Acronym / sponsor ID
- ILBS-Cirrhosis-005
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- All patients with chronic liver disease admitted in ICU (Intensive Care Unit) to be screened.
- Patients fulfilling criteria for feed intolerance to be included in the study.
- 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.
- Patients with ascites to be tested for presence or absence of SBP (Spontaneous Bacterial Peritonitis).
- Cultures to be sent as based on clinical parameter of the patient.
- All correctable causes for intra abdominal hypertension to be corrected including electrolyte imbalance, grade III ascites, intra abdominal infection.
- 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.
- Per abdomen findings to be checked daily including presence of bowel sounds, tenderness, development of abdominal distension, abdominal girth monitoring and abdominal pressure monitoring.
- Patients who develop feed intolerance will be included.
- Feed intolerance to be defined as per study definition (3 out of 5 symptoms).
- Measurement of GRV (Gastric residual volume) to be done at 4 hourly interval.
- 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.
- Once feed intolerance develop than every 6 hourly intra abdominal pressure monitoring and abdominal girth monitoring to be done (24)
- Intra bladder pressure to be measured using Foleys manometer technique (25).
- Pressure measured in cm of water to be converted into mm of Hg.
- 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.
- Development of intra abdominal hypertension based on intra abdominal pressure.
- Patient to be stratified according to the grade of intra-abdominal hypertension.
- 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.
- Daily assessment of bowel sounds, abdominal pressure, abdominal girth every 6 hourly and gastric residual volume to be noted every 4 hourly.
- Response of therapy to be assessed at 24 hours in each arm.
- Response to be assessed by resolution of feed intolerance or initiation of entral nutrition.
- Metoclopromide to be given 10mg iv 8 hourly.
- Erythromycin to be given 70mg iv 12 hourly (26).
- Placebo arm to receive normal saline in 10ml syring twice daily.
- 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.
- Therapy to continue for a total duration of 72 hours.
- If there is no response at 72 hours, than study stops.
- If patient responds to given treatment, study to continue for a total duration of 7 days.
- Assessment to continue in each arm for a maximum period of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metaclopromide group | Experimental | Drug: Metaclopramide |
| Erythromycin group | Experimental | Drug: Erythromycin |
| Placebo group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients who develop new onset feed intolerance to enteral nutrition
Key exclusion criteria (15 listed)
- Any patient with current or past surgical abdomen including mechanical obstruction, mesenteric ischemia, perforation or requiring abdominal surgery.
- Patients receiving enteral nutrition through gastrostomy or jejunostomy.
- Patients in whom, prokinetics are contraindicated or are allergic to the same.
- Patients who received prokinetic more than one day prior to the start of enteral feeding.
- Patients with uncontrolled sepsis with DIC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metaclopramide23. Metoclopromide to be given 10mg iv 8 hourly | Drug | Metaclopromide group |
| ErythromycinErythromycin to be given 70mg iv 12 hourly. | Drug | Erythromycin group |
| Placebo | Other | Placebo group |
Primary outcome
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
7 secondary outcomes
Survival
Time frame: 72 hours
Survival
Time frame: 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
Number of patients with resolution of atleast 2 out of 5 symptoms in all the 3 groups.
Time frame: 72 hours
Number of patients with resolution of sepsis, shock, organ failure in all the 3 groups.
Time frame: 7 days
Number of patients without Ventilatory support in all the 3 groups.
Time frame: 7 days
Number of patients without inotropic supports in all the 3 groups.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metaclopramide and Erythromycin in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of feed intolerance at 24 hours with improvement in 3 or more points and initiation of entral feeding. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.