Pituitary Function After Recovery From Septic Shock Among ICU Survivors

Recruiting now

Conditions studied: Shock, Septic, Pituitary Dysfunction, Hypopituitarism

In brief

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.

Key facts

Study ID: NCT05990491
Run by: Sanjay Gandhi Postgraduate Institute of Medical Sciences
People needed: 90
Starts: 2023-08-28
Expected to finish: 2025-08-01
Last updated by the study team: 2024-10-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Department of Critical Care Medicine, SGPGIMS — Lucknow, Uttar Pradesh, India (enrolling)
Department of Endocrinology, SGPGIMS — Lucknow, Uttar Pradesh, India (enrolling)

Full record on ClinicalTrials.gov

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