🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT05990491
Recruiting Observational

Pituitary Function After Recovery From Septic Shock Among ICU Survivors

NCT05990491 · tracked via the Priya Life Science India tracker
Sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Phase
Observational
Started
2023-08-28
Last updated
2024-10-15

Condition(s) studied

Shock, SepticPituitary DysfunctionHypopituitarism

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Department of Critical Care Medicine, SGPGIMS Lucknow Uttar Pradesh Recruiting
Department of Endocrinology, SGPGIMS Lucknow Uttar Pradesh Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05990491 on ClinicalTrials.gov ↗ ← All trials in India