Assessing Pituitary Function in ICU Survivors of Septic Shock

Pituitary Function After Recovery From Septic Shock Among ICU Survivors: A Prospective, Observational Study

This study is trying to see how septic shock affects hormone levels in patients who have recovered from the ICU, by comparing them to others who were in the ICU for different reasons.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences (other gov)
• Locations: 2 sites (Lucknow, Uttar Pradesh and 1 other locations)
• Trial ID: NCT05990491 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate pituitary function in patients who have recovered from prolonged septic shock after being admitted to the ICU. Participants will have blood samples taken at the time of their discharge from the ICU and again six months later to measure various hormone levels, including cortisol and testosterone. The study seeks to understand the impact of septic shock on pituitary health, which has not been previously explored in this context. By comparing results from septic shock patients to those who experienced other ICU stays without septic shock, the study aims to identify potential dysfunctions in the pituitary gland.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have experienced septic shock requiring ICU admission for more than 7 days.

Not a fit: Patients with pre-existing hypopituitarism or severe chronic illnesses such as advanced kidney or liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of pituitary dysfunction in ICU survivors, potentially improving their long-term health outcomes.

How similar studies have performed: While there have been studies on pituitary dysfunction in other contexts, this specific approach to assessing pituitary function post-septic shock is novel and has not been previously tested.

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.

Where this trial is running

Lucknow, Uttar Pradesh and 1 other locations

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

Study contacts

• Principal investigator: Subhash Yadav — Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Study coordinator: Harilal K, MD

Conditions: Shock, Septic, Pituitary Dysfunction, Hypopituitarism, Septic shock, Post intensive care syndrome