| CTRI Number |
CTRI/2024/04/066049 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Ketofol (drug) for critically ill patients with liver
disease. |
|
Scientific Title of Study
|
Comparison of hemodynamics effects of Etomidate and Ketofol for endotracheal intubation in critically ill patients with liver disease: A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhinav Sharma |
| Designation |
senior resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
D-1, Vasant Kunj
B-6 swasthya vihar
South West
DELHI
110070
India |
| Phone |
8860790151 |
| Fax |
|
| Email |
abhi27sh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shivali Panwar |
| Designation |
Associate Professor |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Liver coma ICU,Faculty Room, 3rd floor,phase II,ILBS,D-1,Vasant kunj, new Delhi-110070
South West
DELHI
110070
India |
| Phone |
9818241779 |
| Fax |
|
| Email |
shivalipanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shivali Panwar |
| Designation |
Associate Professor |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Liver coma ICU,Faculty Room, 3rd floor,phase II,ILBS,D-1,Vasant kunj, new Delhi-110070
South West
DELHI
110070
India |
| Phone |
9818241779 |
| Fax |
|
| Email |
shivalipanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant kunj,New Delhi-110070. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1 VASANT KUNJ |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ABHINAV SHARMA |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
Anesthesia senior resident room, 3rd floor, phase II,ILBS,D-1,Vasant kunj, new Delhi-110070
South West
DELHI |
8860790151
abhi27sh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K721||Chronic hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etomidate |
Dose: 0.2-0.3 mg/kg
Frequency: once only
Route of administration: intravenous
Duration: One time only
|
| Intervention |
Ketofol |
Dose: 1- 2 mg/kg
Frequency:once only
Route of administration: intravenous
Duration: One time only
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18years or more
2. Advanced liver disease with MELDNa 15 or more
3. Undergoing elective endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1. Exclusion criteria:
2. Refusal to consent
3. Allergic to any of the agents being used
4. Pregnancy
5. Patients needing CPR
6. Patients with anticipated difficult airway
7. Acute liver failure
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- To compare the incidence of post intubation hypotension occurring within 6 hours of intubation
between etomidate and ketofol use for sedation during endotracheal intubations in liver ICU |
Within 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 7-day mortality |
first 7 days post intubation |
| Length of ICU stay |
7 days |
| SOFA score at 1 hr and 24 hours post intubation |
1 hr and 24 hrs after intubation |
| Number of days on ventilator |
7 days |
| Total and peak dose of vasopressor requirement within 24 hrs post intubation |
within 24 hours of intubation |
| Number of patients requiring vasopressors within 24 hrs of intubation |
within 24 hours post intubation |
| Fall /Change in MAP from baseline for 1st 6 hours after intubation |
Within 6 hours post intubation |
| Incidence of post intubation hypertension within 6 hours of intubation |
Within 6 hours post intubation |
| Intubation difficulty score |
Day 0 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Importance of study: Post intubation hypotension is a frequent occurrence in ICU. Due to vasodilation seen in patients with advanced liver disease this hypotension is even more profound in these patients. Various agents used to sedate the patient for intubation also impact the occurrence of hypotension as they affect the hemodynamics of the patients. Propofol, Etomidate and ketamine are commonly used sedative-hypnotic agents for this purpose. Ketofol which is an admixture of ketamine and propofol in equal ratios has also been used for this purpose.Etomidate acts by exerting its action of GABA receptors, but is known for its excellent hemodynamic tolerance due to simultaneous stimulation of α-2b adrenoreceptors. Ketamine is a NMDA receptor antagonist. It has sedative and analgesic properties and has a favorable hemodynamic profile as it causes release of endogenous catecholamines. Ketofol is an admixture of propofol and ketamine in equal ratio. This combination combines excellent intubating conditions provided by propofol with a superior hemodynamic profile provided by ketamine without any adrenal suppression. There is paucity of literature comparing the hemodynamics after using ketamine, ketofol and etomidate for sedation for intubation in critically ill liver disease patients. In this study we try to assess and compare the effects of etomidate and ketofol on post intubation hemodynamics in critically ill patients with advanced liver disease. Study population. All Adult Patients with advanced liver disease (MELDNa 15 or more) undergoing elective endotracheal intubation in ICU. Study design: Prospective randomized controlled trial. Allocation concealment: Patients will be randomized to either of two groups ie Group A receiving etomidate and group B receiving ketofol using computer generated random number tables. Group allocation will be sealed in an opaque envelope, which will be opened by ICU nurse not a part of the study. Blinding/Masking: Open label study Methodology Clearance from the institute ethics committee. Informed written consent will be obtained from the patients after explaining the procedure. All patients will have oxygen saturation, pulse rate, ECG and arterial blood pressure monitored. Patients will be randomized to either of two groups i.e. Group A receives etomidate and group B receives ketofol using computer generated random number tables. Group allocation will be sealed in an opaque envelope, which will be opened by an ICU nurse not a part of the study. Pre oxygenation will be done with 100% oxygen using C-circuit and mask for three minutes. After preoxygenation all patients will receive, depending on group allocation either 0.2-0.3 mg/kg etomidate or 1-2 mg/kg ketofol. This will be followed by 1.2 mg/kg injection of rocuronium. Gentle IPPV will be done for 60 seconds. Under direct laryngoscopic guidance trachea will be intubated with appropriate size cuffed endotracheal tube. After confirmation of bilateral equal air entry the tube will be fixed. Ventilator will be connected with standard mode of ventilation. Baseline heart rate, mean arterial pressure, oxygen saturation and vasopressor requirement will be noted prior to induction. These readings will be recorded post intubation as soon as the cuff is inflated and then every minute for next 5 minutes thereafter every five minutes till 30 minutes and then hourly till 6 hours. Hypotension will be defined as MAP< 65 mmhg or more than 20% decrease in MAP from baseline (8). Length of ICU stay, 7-day ,28 day mortality, ICU, ventilator , hospital and vasopressor free days till 28 days will also be noted and compared between the groups. SOFA score will be noted prior to intubation and 24 hours post intubation. Any hypertension ( BP >140/90) within 5 minutes post intubation will be noted. Intubation difficulty score will be assessed.
Monitoring and assessment: Baseline heart rate, mean arterial pressure, oxygen saturation and vasopressor requirement will be noted prior to induction. These readings will be recorded post intubation as soon as the cuff is inflated and then every minute for next 5 minutes thereafter every five minutes till 30 minutes and then every hourly till 6 hours. Hypotension will be defined as MAP< 65 mmhg or more than 20% decrease in MAP from baseline. Length of ICU stay, 7-day ,28 day mortality, ICU, hospital and vasopressor free days till 28 days and number of days on ventilator will also be noted and compared between the groups. SOFA score will be noted prior to intubation and 24 hours post intubation.
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