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CTRI Number  CTRI/2024/10/074767 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [pragmatic single centre parallel group, Accessor Blind investigator led randomized trial]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A single-center parallel-group randomized study to evaluate customized patient care with the standard of care as per the guidelines for the treatment of low blood pressure in seriously ill patients having shock, which means a sudden fall in blood pressure.  
Scientific Title of Study   Individualized Resuscitation in Early Septic Shock( first 3 hours of Resuscitation) A single centre parallel group randomised controlled trial 
Trial Acronym  IRESS Study 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4236 Version 2.0 dated 15.12.2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila Nainan Myatra 
Designation  Professor  
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr.Earnest Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheila Nainan Myatra 
Designation  Professor  
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr.Earnest Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sheila Nainan Myatra 
Designation  Professor  
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr.Earnest Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road, Parel, Mumbai, Maharashtara India 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
None  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila Myatra  Tata Memorial Hospital, Mumbai  Room No MB101 and MB201, Intensive Care Unit, First and Second floor, Main Building, Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA 
9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee-II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I958||Other hypotension, (2) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Management (IM) group  In this group first of all fluid responsiveness is checked by dynamic measures. If patient is fluid responsive, 10 ml/kg (Ideal Body Weight) of IV crystalloids are given bolus and CRT & MAP are measured. If CRT is 3 sec or MAP 65 mmhg, another 10 ml/kg IV crystalloids are given. If the patient is mechanically ventilated, the variable used for reducing the rate of infusion will be increase in FiO2 requirement &/or PEEP to maintain target spo2 as decided by treating clinician. This fluid administration may be repeated if patient is fluid responsive and Fluid tolerant as discussed above until goals of resuscitation are met like MAP ≥ 65 mmhg & CRT ≤ 3 sec or Lactate 2 mmol/L 
Comparator Agent  Standard of Care management group  In this group, patient will receive total of 30ml/kg of IBW Intravenous fluid boluses during the period of early sepsis i.e. 1st three hours. If the patient saturation falls &/or respiratory rate increased, the rate of administration and the total amount of fluid can be reduced as decided by the clinician. Here also the end target will be MAP 65 mmhg and CRT 3 sec. CRT will be measure after each 10ml/kg fluid bolus during our study period while lactate is measured at baseline and at 3 hour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult patient (more than equal to 18 years) with sepsis induced hypotension or septic shock as per Sepsis 3 consensus conference 
 
ExclusionCriteria 
Details  1. Received more than 10ml/kg of intravenous crystalloids before randomization in last 3 hours
2. Do not resuscitate status
3. Anticipated surgery or acute hemodialysis procedure to start during the first 3 hour period
4. Child B-C Cirrhosis
5. Pregnancy
6. Treating Physicians feel use of fluid bolus or vasopressor is strongly indicated or contraindicated
7. Age less than 18 years
8. Inability to take consent from surrogate
9.Vasopressors stopped less than 24 hours before
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
All cause mortality within 28 days after randomization  28 days after randomisation 
 
Secondary Outcome  
Outcome  TimePoints 
Length of ICU Stay.  till discharge from Intensive care unit after enrollment 
Number of days free from ventilator use (within 28 days after randomization).  till day 28 or ICU discharge or Death, whichever come first 
Days free from vasopressor use (within 28 days after randomization).  till day 28 or ICU discharge or Death, whichever come first 
Days free from Renal Replacement therapy (within 28 days after randomization)  till day 28 or ICU discharge or Death, whichever come first 
Death during period of early resuscitation (within 3 hours)  upto 3 hrs post randomisation 
Time to CRT normalization  till day 28 or ICU discharge or Death, whichever come first 
Lactate reduction by 3rd hour  upto 3 hrs post randomisation 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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   N/A 
Date of First Enrollment (India)   28/10/2024 
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="2"
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  

Fluid therapy is commonly necessary to treat patients in the critical care unit who experience a fast drop in blood pressure due to a bloodstream infection. IV fluids are quickly injected into the veins of the patient as part of this fluid therapy. Only 50% of patients, meanwhile, benefit from this fluid treatment and do not have organ failure. In the first three hours of therapy, a patient in shock should receive at least 30 milliliters of intravenous fluid for every kilogram of body weight, according to established standards. This lowers the risk of hypotension and septic shock, although clinical research has not supported these recommendations.

However, not all low blood pressure patients respond to fluid therapy in the same manner, which can have major adverse effects like edema and excess fluid in the lungs that restrict oxygen flow. The recommended standard volume of 30 ml/kg of body weight may not be enough for certain persons, and it may induce an accumulation of extra water in blood vessels for others. Therefore, it’s essential to utilize the right kind and quantity of fluid while treating low blood pressure. Furthermore, it is necessary to regularly assess the effects of fluid therapy because the 3-hour treatment interval recommended by the conventional guidelines to do so is unreliable.

Controlling the amount of fluid supplied requires a thorough evaluation in order to avoid both excess- and less-treatment and the associated complications. According to one study analysis, there is a significant relationship between the decrease in number of deaths, a reduction in ICU stay, and less time spent on breathing machines when fluid treatment is given using the dynamic approach instead of the standard method. We want to conduct this research to compare the benefits of customized management—using dynamic assessments for evaluating the effect of fluid therapy and conventional management using the standard amount of 30 ml/kg fluid volume for fluid administration during the early stages of hypotension caused due to the severe infections.

In this study, we are making the assumption that, using a dynamic approach to fluid administration in the treatment of initial stages (i.e first 3 hours of treatment) of hypotension resulting from a severe infection will dramatically reduce the number of deaths as compare to the standard method.

Benefits

The patients enrolled in the trial may or may not be directly benefitted from participating in the trial but the results obtained from the study may help the clinicians in the treatment of future patient treatment.

Safety Intervention

Any side effects that occur during the treatment of early infection will be treated as per the ICU doctor decision. Participants will receive all other medicines and the standard of care treatment as per the ICU doctor’s decision during the intervention period.

The treating clinician and investigator may choose to reduce the fluid therapy and rate of administration of fluids if necessary or even stop it if there is a drop in oxygen level, an increase in respiratory rate, increase in an oxygen demand, and/or pressure to provide oxygen.

 
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