Pituitary Function After Recovery From Septic Shock Among ICU Survivors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSanjay Gandhi Postgraduate Institute of Medical Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Patients 18-80 years of age who planned for discharge from the ICU.with stay for a duration of >7 days.

Disqualifiers

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.

Trial population

Consecutive patients admitted to critical care medicine intensive care unit at Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow who meet the inclusion and exclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: Septic shock group
Group B: Non-septic shock group

Trial outcomes

Primary outcomes

1

Pituitary dysfunction at discharge

Frequency of dysfunction of various hypothalamo-pituitary hormone axes

Time frame
Immediately before the ICU discharge

Secondary outcomes

1

Pituitary dysfunction at 6 months

Frequency of dysfunction of various hypothalamo-pituitary hormone axes on follow up

Time frame
Six months after the ICU discharge

Other outcomes

Sponsors and contacts

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