Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-06 @ 6:45 PM
Study NCT ID:
NCT02528760
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2015-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis- A Randomized Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: