Pituitary Function After Recovery From Septic Shock Among ICU Survivors

NCT05990491 | Recruiting

• 1 other identifier: A-05-PGI/IMP/87/2023
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Prolonged circulatory shock is associated with marked disturbances in vascular supply to the brain, and endothelial dysfunction which can lead to disseminated intravascular coagulation and microvascular thrombosis. Pituitary dysfunction is documented following post-partum hemorrhage, traumatic brain injury and subarachnoid hemorrhage, which also affect blood flow to the pituitary. However, there are no studies assessing pituitary function in the aftermath of recovery from shock. This will be a prospective observational study of patients admitted in Critical Care Medicine (CCM) ICU who have recovered from prolonged septic shock (Lasting for a period of \> 24 hours). Blood samples of the participants will be estimated at the time of discharge from the ICU and at 6 months post discharge. Investigators will estimate fasting serum cortisol, TSH, Free T4, Testosterone (in males), Oestrogen (in females), LH, FSH, Prolactin, IGF-1 and plasma ACTH in all participants at both time points (at the time of ICU discharge and at 6-months follow-up). Participants who have borderline serum cortisol values (138-400 nmol/l) will be subjected to 250ug ACTH stimulation test. Expected outcome of the proposed study is to know proportion of patients having pituitary hormone axis dysfunction. Investigators will also look for pituitary dysfunction persist or revert, or there are new onset dysfunction at 6 month follow up. This would have major implications in the follow up and management of ICU survivors.

Conditions

Shock, Septic; Pituitary Dysfunction; Hypopituitarism

Keywords

Septic shock; Post intensive care syndrome; Hypopituitarism

Outcome Measures

Primary Outcomes (1)

• Pituitary dysfunction at discharge

  Frequency of dysfunction of various hypothalamo-pituitary hormone axes

  Immediately before the ICU discharge

Secondary Outcomes (1)

• Pituitary dysfunction at 6 months

  Six months after the ICU discharge

Study Arms (2)

Septic shock group

Patients 18-80 years of age who meet the definition of septic shock. Vasopressor requirement should be maintained for a period \>24 hours and should require ICU stay for a duration of \> 7 days. Patient should recover from shock and be planned for discharge from the ICU.

Non-septic shock group

Patients 18-80 years of age who planned for discharge from the ICU.with stay for a duration of \>7 days. Also, they should not have received vasopressor for.a period of \>24 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients admitted to critical care medicine intensive care unit at Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow who meet the inclusion and exclusion criteria

You may qualify if:

• Septic shock group:
• Patients 18-80 years of age who meet the definition of septic shock.
• Vasopressor requirement should be maintained for a period \> 24 hours and should require ICU stay for a duration of \> 7 days.
• Patient should recover from shock and be planned for discharge from the ICU
• Non-septic shock group
• Patients 18-80 years of age who planned for discharge from the ICU.with stay for a duration of \>7 days.
• Also, they should not have received vasopressor for.a period of \>24 hours

You may not qualify if:

• Patients who refuse to provide consent.
• Age \<18 years or \> 80 years of age.
• Pregnancy or immediate post-partum (\< 6 months post-delivery).
• Chronic kidney disease (Stage 5), chronic liver disease (CHILD B or C), severe Chronic obstructive pulmonary disease, Chronic heart failure.
• Patients with pre-existing hypopituitarism on replacement.
• Past history of severe post-partum hemorrhage requiring blood transfusion, traumatic brain injury, subarachnoid hemorrhage, pituitary tumor/surgery, snake bite envenomation and meningo-encephalitis.
• Patients who have been on \> 5 mg prednisolone equivalent for a period of more than 2 weeks at any time in the previous 6 months before admission.

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (2)

Department of Critical Care Medicine, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

Department of Endocrinology, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (8-10 ml) collected at the time of recruitment and at 6 months follow-up.

MeSH Terms

Conditions

Shock, Septic; Hypopituitarism; postintensive care syndrome

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Subhash Yadav

  Sanjay Gandhi Postgraduate Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohan Gurjar

  Sanjay Gandhi Postgraduate Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Jayakrishnan C, DM

  Sanjay Gandhi Postgraduate Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harilal K, MD

CONTACT

+91-8089728532; hari2012686@gmail.com

Jayakrishnan C, DM

CONTACT

+91-8281868653; jake3129@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: July 30, 2023
• First Posted: August 14, 2023
• Study Start: August 28, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)