Actively Recruiting
Pituitary Function After Recovery From Septic Shock Among ICU Survivors: A Prospective, Observational Study
Led by Sanjay Gandhi Postgraduate Institute of Medical Sciences · Updated on 2024-10-15
90
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates pituitary gland function in adults who have recovered from prolonged septic shock after an intensive care unit (ICU) stay. Septic shock can cause poor blood flow and damage to the pituitary, a gland important for hormone regulation. The study aims to determine how common pituitary hormone problems are at ICU discharge and whether these problems persist, improve, or newly develop six months later. This knowledge could influence follow-up care for ICU survivors. Participants include adults aged 18 to 80 who have recovered from septic shock requiring vasopressors for over 24 hours and an ICU stay longer than 7 days, as well as a comparison group without septic shock but with similar ICU stays. The study collects blood samples at ICU discharge and again six months later to measure various pituitary hormones, including cortisol, ACTH, sex hormones, thyroid hormones, and growth factors. Those with borderline cortisol levels will have an additional stimulation test. Participants will be interviewed by phone three months after discharge to assess quality of life and symptoms related to pituitary dysfunction. Hormone levels and quality of life assessments will be repeated six months post-discharge. Researchers will analyze hormone changes over time and relate findings to participants’ clinical history and treatments. The study lasts approximately six months for each participant, focusing on hormone function and long-term recovery after septic shock.
CONDITIONS
Brief Title
Pituitary Function After Recovery From Septic Shock Among ICU Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years
- Septic shock group: vasopressor support for more than 24 hours and ICU stay longer than 7 days
- Planned discharge from ICU after recovery from shock (for septic shock group)
- Non-septic shock group: ICU stay longer than 7 days without vasopressor support for more than 24 hours
- Planned discharge from ICU (for non-septic shock group)
You will not qualify if you...
- Refusal to provide consent
- Age less than 18 years or greater than 80 years
- Pregnancy or within 6 months after delivery
- Chronic kidney disease stage 5
- Chronic liver disease Child-Pugh class B or C
- Severe chronic obstructive pulmonary disease
- Chronic heart failure
- Pre-existing hypopituitarism on hormone replacement
- History of severe postpartum hemorrhage requiring transfusion
- History of traumatic brain injury, subarachnoid hemorrhage, pituitary tumor or surgery
- History of snake bite envenomation or meningo-encephalitis
- Use of more than 5 mg prednisolone equivalent for over 2 weeks within 6 months prior to admission
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to ICU discharge (variable depending on recovery)
Participants undergo assessment of pituitary hormone levels and clinical parameters prior to ICU discharge to evaluate pituitary function.
1 visit (in-person) prior to ICU discharge
Duration - 3 months post-ICU discharge
Participants are interviewed telephonically at 3 months post-ICU discharge to assess quality of life and symptoms related to pituitary dysfunction.
1 telephone interview
Duration - 6 months post-ICU discharge
Participants undergo repeat assessment of pituitary hormone levels and quality of life evaluation at 6 months post-ICU discharge to monitor recovery or new onset pituitary dysfunction.
1 visit (in-person) at 6 months post-discharge
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
J
Jayakrishnan C, DM
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
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