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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
India
Department of Critical Care Medicine, SGPGIMS
RECRUITING
Lucknow
Department of Endocrinology, SGPGIMS
RECRUITING
Lucknow
Contact Information
Primary
Harilal K, MD
hari2012686@gmail.com
+91-8089728532
Backup
Jayakrishnan C, DM
jake3129@gmail.com
+91-8281868653
Time Frame
Start Date: 2023-08-28
Estimated Completion Date: 2025-08
Participants
Target number of participants: 90
Treatments
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
Sponsors
Leads: Sanjay Gandhi Postgraduate Institute of Medical Sciences

This content was sourced from clinicaltrials.gov

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