Actively Recruiting
Pituitary Function After Recovery From Septic Shock Among ICU Survivors
Led by Sanjay Gandhi Postgraduate Institute of Medical Sciences · Updated on 2024-10-15
90
Participants Needed
2
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pituitary Function After Recovery From Septic Shock Among ICU Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 80 years who meet the definition of septic shock.
- Vasopressor treatment required for more than 24 hours with ICU stay longer than 7 days.
- Patients who have recovered from shock and are planned for ICU discharge.
- Patients aged between 18 and 80 years planned for ICU discharge with an ICU stay longer than 7 days.
- Patients without vasopressor treatment for more than 24 hours in the non-septic shock group.
You will not qualify if you...
- Patients who refuse to provide consent.
- Age under 18 years or over 80 years.
- Pregnancy or within 6 months post-partum.
- Chronic kidney disease stage 5, chronic liver disease CHILD B or C, severe COPD, or chronic heart failure.
- Pre-existing hypopituitarism on hormone replacement therapy.
- History of severe post-partum hemorrhage requiring blood transfusion, traumatic brain injury, subarachnoid hemorrhage, pituitary tumor or surgery, snake bite envenomation, or meningo-encephalitis.
- Use of prednisolone equivalent over 5 mg daily for more than 2 weeks within the last 6 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Critical Care Medicine, SGPGIMS
Lucknow, Uttar Pradesh, India, 226014
Actively Recruiting
2
Department of Endocrinology, SGPGIMS
Lucknow, Uttar Pradesh, India, 226014
Actively Recruiting
Research Team
H
Harilal K, MD
CONTACT
J
Jayakrishnan C, DM
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here