| CTRI Number |
CTRI/2022/03/041092 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
a research done to see if muscle girth of thigh measured using ultrasound can be linked with a nutritional component in very sick icu patients |
|
Scientific Title of Study
|
Correlation of calorie:N2 ratio delivered among critically ill patients having severe sepsis with change in quadriceps thickness assessed by ultrasonography- A Cross sectional study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayur Ramakrishna |
| Designation |
Specialist Intensivist |
| Affiliation |
Nizwa Hospital |
| Address |
Nizwa Hospital
Ministry of health
Department of Anesthesia and Critical care medicine
Adult ICU
Oman
611
Other |
| Phone |
00-968-71139687 |
| Fax |
|
| Email |
mayur.verma317@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mayur Ramakrishna |
| Designation |
Specialist Intensivist |
| Affiliation |
Nizwa Hospital |
| Address |
Nizwa Hospital
Ministry of Health
Department of Anesthesia and Critical care
Adult ICU
Oman
611
Other |
| Phone |
00-968-71139687 |
| Fax |
|
| Email |
mayur.verma317@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayur Ramakrishna |
| Designation |
Specialist Intensivist |
| Affiliation |
Nizwa Hospital |
| Address |
Nizwa Hospital
Ministry of Health
Department of Anesthesia and Critical care
Adult ICU
Oman
611
Other |
| Phone |
00-968-71139687 |
| Fax |
|
| Email |
mayur.verma317@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Nizwa Hospital |
| Address |
Nizwa Hospital
PO Box 1222
Postal code- 611
MINSTRY OF HEALTH
NIZWA
SULTANATE OF OMAN |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
Oman |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mayur Ramakrishna |
Nizwa Hospital |
Department of Anesthesia and Intensive care
MDICU- Adult ICU
|
00-968-71139687
mayur.chillal31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Research and Ethical Review and Approve Committe (RERAC) |
Approved |
| Research and Ethical Review and Approve Committe (RERAC) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 All patients admitted to multi disciplinary ICU with severe sepsis as defined by sepsis 3 guidelines
2 Age group – 18 yrs to 60 yrs
|
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| ExclusionCriteria |
| Details |
1 Obese patients – whose BMI > 30
2 Muscle disorders- including myositis/rhabdomyolysis
3 Patients with disuse atrophy of muscles – eg- stroke/quadriplegics/paraplegics
4 Burns patients
5 Pregnant patients
6 Patients on total parentral nutrition
7 Patients in whom enteral nutrition is contraindicated
8 Malabsorption syndrome
9 Patients who are not willing for the study
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for any statistical correlation between the cumulative mean of the calorie:n2 ratio with that of quadriceps muscle thickness |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To be able to establish the time duration for any change in muscle thickness in severe sepsis patients – USG guided demonstrable change |
1 year |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
not yet completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Patients coming under severe sepsis criteria will be considered for the study- those admitted to MDICU since day 1, their calorie:n2 ratio obtained from the nutritional registry maintained in our hospital is calculated daily and at the same time quadriceps muscle girth of the patient is measured using USG method, where rectus femoris, vastus intermidius muscle is visualized from a linear probe of 8-12 MHz kept at anterior 2/3rd and 1/3 of the thigh measuring from the anterior superior iliac spine and the superior margin of the patella and patient maintained in supine position with both legs kept in a neutral position
we have a standardized protocol for measuring muscle girth- unfortunately, pictures cant be posted here as soft ware not supported to paste.
The cumulative mean of calorie:n2 ratio is taken and compared with muscle girth cumulative mean to ascertain if there is any statistical correlation
as per our hypothesis, we believe there is a correlation between the two parameters
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