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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.

Individualized Resuscitation in Early Septic Shock( first 3 hours of Resuscitation) A single centre parallel group randomised controlled trial - IRESS Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074767
Enrollment
350
Registered
2024-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I958- Other hypotension Health Condition 2: A419- Sepsis, unspecified organism

Interventions

Intervention1: 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

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patient (more than equal to 18 years) with sepsis induced hypotension or septic shock as per Sepsis 3 consensus conference

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
All cause mortality within 28 days after randomizationTimepoint: 28 days after randomisation

Secondary

MeasureTime frame
Days free from Renal Replacement therapy (within 28 days after randomization)Timepoint: till day 28 or ICU discharge or Death, whichever come first;Days free from vasopressor use (within 28 days after randomization).Timepoint: till day 28 or ICU discharge or Death, whichever come first;Death during period of early resuscitation (within 3 hours)Timepoint: upto 3 hrs post randomisation;Lactate reduction by 3rd hourTimepoint: upto 3 hrs post randomisation;Length of ICU Stay.Timepoint: till discharge from Intensive care unit after enrollment;Number of days free from ventilator use (within 28 days after randomization).Timepoint: till day 28 or ICU discharge or Death, whichever come first;Time to CRT normalizationTimepoint: till day 28 or ICU discharge or Death, whichever come first

Countries

India

Contacts

Public ContactDr Sheila Nainan Myatra

Tata Memorial Hospital

sheila150@hotmail.com9820156070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026