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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metaclopromide group | Experimental |
| |
| Erythromycin group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metaclopramide | Drug | 23. Metoclopromide to be given 10mg iv 8 hourly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 72 hours | |
| Survival | 7 days | |
| Number of patients with Initiation of entral nutrition more than 50%. of recommended nutrition (Kcal/kg body weight/day). |
Not provided
Inclusion Criteria:
1. Patients who develop new onset feed intolerance to enteral nutrition
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Erythromycin |
| Drug |
Erythromycin to be given 70mg iv 12 hourly. |
|
| Placebo | Other |
|
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. | 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. | 7 days |
| Number of patients without Ventilatory support in all the 3 groups. | 7 days |
| Number of patients without inotropic supports in all the 3 groups. | 7 days |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |