Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients

NCT06363149 | Recruiting

• 1 other identifier: 2024-11-DM-136
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Septic shock is common complication in patients with critical illnesses, with higher incidence in low and medium income countries like ours. Disseminated intravascular coagulation (DIC) is also common in patients presenting to intensive care units. Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock. Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold. Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply. DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC. Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention. Also, there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock.

Conditions

Septic Shock; Disseminated Intravascular Coagulation

Keywords

Critical Illnesses; Multiple Organ Dysfunction Syndrome

Outcome Measures

Primary Outcomes (1)

• Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 7

  Correlation of Disseminated Intravascular Coagulation score (0 to 8, where higher score is severe) and its change with the organ dysfunction measured as Sequential Organ Failure Assessment score (0 to 24, where higher score has worse outcome)

  At day 7 after inclusion

Secondary Outcomes (1)

• Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 14

  At day 14 after inclusion

Study Arms (1)

Septic shock

Adult ICU patients having septic shock as defined by Sepsis -3 definition requiring vasopressor for at least 12 hours duration will be considered for inclusion in this observational study..

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult ICU patients having septic shock as defined by Sepsis -3 definition requiring vasopressor for at least 12 hours duration will be considered.

You may qualify if:

• Adult ICU patients having septic shock as defined by Sepsis -3 definition requiring vasopressor for at least 12 hours duration will be considered.

You may not qualify if:

• Age less than 18 years or more than 65 years
• Expected survival less than 72 hours
• Caregiver refused for the consent to participate in the study

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Disseminated Intravascular Coagulation; Critical Illness; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia; Disease Attributes

Study Officials

• Mohan Gurjar, MD, PDCC

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

• Dinesh Chandra, MD, DM

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Gurjar, MD, PDCC

CONTACT

+91-522-249-5403; m.gurjar@rediffmail.com

Sanjay Chaudhary, MD

CONTACT

+91-522-249-4540; sanjaychaudhary2282@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: April 12, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

IN (1)