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Clinical Trials/CTRI/2025/03/082235
CTRI/2025/03/082235
Recruiting
Not Applicable

Evaluating prognosis in septic shock patient using various perfusion markers during resuscitation

Dr Ekta Tiwari1 site in 1 country70 target enrollmentStarted: April 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Dr Ekta Tiwari
Enrollment
70
Locations
1
Primary Endpoint
To determine the correlation between the three perfusion markers (lactate level, capillary refill time & P(c-va) co2 gradient) in hospital

Overview

Brief Summary

This prospective, observational study will be conducted in the critical care department at Holy Family Hospital, New Delhi, focusing on patients over 18 years of age with septic shock admitted to the ICU. The study will follow the Surviving Sepsis Campaign (SSC) 2021 guidelines for managing septic shock, including optimizing preload with fluid resuscitation and vasopressor infusion to maintain a MAP greater than or equal to 65 mmHg. Various dynamic resuscitation measures, such as pulse pressure variation, inferior Vena cava assessment, and mini fluid challenge, will guide fluid therapy. Safety indicators, such as clinical judgement and lung ultrasound findings, will be used to adjust fluid and vasopressor therapy. A multimodal perfusion assessment will be performed at baseline and at multiple time points (3,6,12 and 24 hours) after resuscitation, including macro-hemodynamic variables, lactate clearance, and peripheral perfusion assessment via capillary refill time. All patients will be followed up until discharge or for 30 days, collecting data on demographics, sepsis sources, management, and clinical parameters for analysis.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.All patients more than 18 years of age admitted in ICU with sepsis shock.
  • 2.Patient presenting with septic shock.
  • (According to sepsis-3 definition, Septic shock is defined as persistent hypotension despite adequate fluid resuscitation and need for vasopressor requirement to target mean arterial pressure (MAP) more than or equal to 65mmhg more than 2 mmol per L blood lactate levels and as per dynamic fluid resuscitation.
  • 3.Patients in those central line can be inserted.

Exclusion Criteria

  • 1.Age less than 18 years 2.Pregnancy & lactating women 3.Patient with congestive heart failure 4.Patient with active bleed 5.Patient refusing for consent for enrolment in the study 6.Inability to insert central insertion.

Outcomes

Primary Outcomes

To determine the correlation between the three perfusion markers (lactate level, capillary refill time & P(c-va) co2 gradient) in hospital

Time Frame: 0, 3, 6, 12, 24 hours.

Secondary Outcomes

  • In hospital mortality(30 days)
  • Organ Failure(1st, 3rd day)
  • Vasopressor dose & duration(At discharge)
  • Fluid requirements(12hr, 24 hrs)
  • Need of Invasive mechanical ventilation & duration of mechanical ventilation in days.(At discharge)
  • Need for RRT & number of days on RRT (Renal Replacement Therapy)(At discharge)
  • Cumulative fluid balance(Day1, Day3)
  • ICU & Hospital Length of Stay(At discharge)

Investigators

Sponsor
Dr Ekta Tiwari
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ekta Tiwari

Holy Family Hospital

Study Sites (1)

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