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Shock, SepticNCT05990491

Pituitary Function After Recovery From Septic Shock Among ICU Survivors

An observational study of Shock, Septic and Pituitary Dysfunction, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 2 sites in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
90 participants
Where
2 sitesIndia
Study dates
28 Aug 2023to Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jayakrishnan C, DM contact

+91-8281868653

jake3129@gmail.com

India2 sites, 2 recruiting
  • Department of Critical Care Medicine, SGPGIMS

    Lucknow, Uttar Pradesh, 226014

    Mohan Gurjar, MD, PDCC, 915222495403, m.gurjar@rediffmail.com

    Recruiting
  • Department of Endocrinology, SGPGIMS

    Lucknow, Uttar Pradesh, 226014

    Harilal K, MD, +91-8089728532, hari2012686@gmail.com

    Jayakrishnan C, DM, +91-8281868653, jake3129@gmail.com

    Recruiting

Other trials in India

About this study

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

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.

Read the detailed description

The pituitary gland receives its arterial blood supply from the superior and inferior hypophyseal arteries, which arise from the internal carotid artery. The infundibulum, the median eminence and the pars tuberalis are supplied by the superior hypophyseal artery and the posterior lobe by the inferior hypophyseal artery. By contrast, the pars distalis (anterior pituitary) is mainly supplied by the venous system. The long portal system, arising from the capillary plexus around the median eminence, and the short portal system arising from the posterior pituitary account for 70% and 30% respectively, of the total blood supply to the anterior pituitary gland. This unique circulation allows the pars distalis to receive humoral signals from the hypothalamus and the posterior pituitary; however, it renders the pituitary susceptible to ischemia due to hypotension, hypovolemia and vascular thrombosis.

The prototype illness where pituitary necrosis leads to pituitary dysfunction is post-partum pituitary necrosis (Sheehan syndrome). The pituitary gland becomes vulnerable to changes in blood flow during and shortly after pregnancy owing to the increased size of the gland, leading to both increased demand and compression of the vasculature of the gland. In addition, pregnancy is a thrombophilic state which increases risk for intravascular thrombosis. Hypotension secondary to post-partum hemorrhage causes pituitary necrosis and leads to hypopituitarism. Vascular insults to the pituitary are also implicated in other forms of pituitary damage, such as following traumatic brain injury, following snakebite envenomation, subarachnoid hemorrhage and hemorrhagic shock.

Circulatory shock replicates many of the pathophysiological processes described above. Clinical classifications of shock include hypovolemic, cardiogenic, distributive (septic), and obstructive types. While the pathophysiology of each type of shock is different and complex, the final common pathway is poor perfusion, anaerobic metabolism, lactic acidosis, and release of inflammatory mediators with resultant tissue damage. Sepsis and septic shock are often complicated by Disseminated Intravascular Coagulation (DIC) which leads to widespread microvascular thrombosis. Hypotension leads to reduced blood flow to the hypothalamo-pituitary unit and all these factors may lead on to ischemia and infarction of the hypothalamo-pituitary unit. Patients who recovered post cardiac arrest suffer an extreme form of this insult where blood flow to the brain is almost entirely cut off for a period of time, followed by reperfusion.

Post ICU Care Syndrome (PICS) is estimated to occur in 30-80% of patients post discharge from the intensive care unit. Many of the manifestations of Post ICU Care Syndrome (PICS), such as fatigue, cognitive dysfunction, neuromuscular weakness, amenorrhea and sexual dysfunction overlap with those seen in hypopituitarism. However, there is no literature describing the role of pituitary dysfunction in these patients.

Based on the above evidence, we hypothesize that patients who recover from severe shock may have hypothalamic-pituitary damage leading to hypopituitarism. Due to the current lack of literature on this topic, we propose to study pituitary function in ICU survivors who recovered from the septic shock.

The primary objective is to study the prevalence of dysfunction of various pituitary hormone axes at the time of ICU discharge in participants who recovered from the septic shock. The secondary objective is to look for the recovery of pituitary function or new onset pituitary dysfunction at 6 months post-discharge from the ICU, in these included participants.

This will be a prospective, observational study of participants undergoing treatment for septic shock in the Department of Critical Care Medicine (CCM), SGPGIMS, Lucknow.

Details of premorbid conditions, precipitating illness, clinical parameters and treatments provided to the participants will be recorded. Levels of pituitary hormones [Cortisol (Basal and stimulated), ACTH, IGF-1, LH, FSH, Testosterone (in males), Estradiol (in females), Prolactin, TSH and free T4] will be assessed in fasting state, prior to discharge from the ICU. Participants will be interviewed telephonically at 3 months post-discharge to assess quality of life using the SF-36 questionnaire and for symptoms suggestive of hypopituitarism. At 6 months post-discharge, the various pituitary hormone levels [Cortisol (Basal and stimulated), ACTH, IGF-1, LH, FSH, Testosterone (in males), Estradiol (in females), Prolactin, TSH and free T4] will be assessed again along with assessment of quality of life using SF-36. Any pituitary hormone deficiency identified on testing will be evaluated and managed as per standard practice.

Investigators aim to include 90 participants in the study. Continuous variables will be presented in mean and standard deviation (SD) or median (interquartile range) depending upon normality status. Independent samples t test (for independent groups) / Paired t test (paired groups) or their non-parametric counterparts will be used to compare the means or medians between the groups, respectively. Categorical variables will be presented in number (%) and will be compared by Chi square test / Fisher exact test, as appropriate. One-way Repeated Measures ANOVA or Friedman test will be used to compare the means or medians over the time as appropriate. Binary logistic regression analysis will be used to assess the factors associated with pituitary dysfunction among the study participants.

Keywords
Septic shock, Post intensive care syndrome, Hypopituitarism
Medical subject headings
Shock, Septic, Hypopituitarism, postintensive care syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05990491
Study groupRoleWhat they receive
Septic shock groupPatients 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 groupPatients 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pituitary dysfunction at discharge

    Frequency of dysfunction of various hypothalamo-pituitary hormone axes

    Measured: Immediately before the ICU discharge

Secondary outcomes (1)
  1. Pituitary dysfunction at 6 months

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

    Measured: Six months after the ICU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start28 Aug 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05990491
Sponsor's protocol ID
A-05-PGI/IMP/87/2023
Status last verified
Oct 2024
First submitted
30 Jul 2023
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Shock, Septic and Pituitary Dysfunction, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Harilal K, MD (+91-8089728532, hari2012686@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pituitary dysfunction at discharge (time frame: Immediately before the ICU discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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