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.
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
- Conditions the study is for
- Shock, Septic, Pituitary Dysfunction, Hypopituitarism
- 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.
India2 sites, 2 recruiting
- 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
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.
- Conditions
- Shock, Septic, Pituitary Dysfunction, Hypopituitarism
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pituitary dysfunction at discharge
Frequency of dysfunction of various hypothalamo-pituitary hormone axes
Measured: 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
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.
- First posted14 Aug 2023
- Study start28 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohan Gurjar, Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Investigators
- Subhash Yadav, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical SciencesMohan Gurjar, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical SciencesJayakrishnan C, DM, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pituitary Function After Recovery From Septic Shock Among ICU Survivors: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05990491
- Acronym / sponsor ID
- A-05-PGI/IMP/87/2023
- Conditions
- Shock, Septic, Pituitary Dysfunction, Hypopituitarism
- Keywords
- Septic shock, Post intensive care syndrome, Hypopituitarism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pituitary dysfunction at discharge
Time frame: Immediately before the ICU discharge
Frequency of dysfunction of various hypothalamo-pituitary hormone axes
1 secondary outcome
Pituitary dysfunction at 6 months
Time frame: Six months after the ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Subhash Yadav principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Mohan Gurjar principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Jayakrishnan C, DM principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
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.