NCT05990491 Pituitary Function After Recovery From Septic Shock Among ICU Survivors
| NCT ID | NCT05990491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Condition | Shock, Septic |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-08-28 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2023-08-28 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Subhash Yadav
PRINCIPAL INVESTIGATOR
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Frequently Asked Questions
Who can join the NCT05990491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Shock, Septic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05990491 currently recruiting?
Yes, NCT05990491 is actively recruiting participants. Contact the research team at hari2012686@gmail.com for enrollment information.
Where is the NCT05990491 trial being conducted?
This trial is being conducted at Lucknow, India, Lucknow, India.
Who is sponsoring the NCT05990491 clinical trial?
NCT05990491 is sponsored by Sanjay Gandhi Postgraduate Institute of Medical Sciences. The principal investigator is Subhash Yadav at Sanjay Gandhi Postgraduate Institute of Medical Sciences. The trial plans to enroll 90 participants.