Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190994
Recruitment Status : Unknown
Verified July 2014 by Shu Jiang, West China Hospital.
Recruitment status was:  Recruiting
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Shu Jiang, West China Hospital

Brief Summary:
The purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of pituitary function and other postoperative complications (infection, pain, quality of life, recurrence). Surgical patients of our center with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT) will be performed for assessment of the pituitary function at enrollment. Patients with normal pituitary function will be randomized into non-GC replacement group (group A) and low-dose GC replacement group (group B), while patients with impaired pituitary function will be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH, thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance, infection, recurrence and health-related quality of life.

Condition or disease Intervention/treatment Phase
Pituitary Neoplasms Craniopharyngiomas Drug: Hydrocortisone Drug: Prednisone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Study Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
No Intervention: A. Normal function, non-GC replacement
No glucocorticoid replacement will be given perioperatively.
Active Comparator: B. Normal function, low-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
Drug: Hydrocortisone
used intravenously

Drug: Prednisone
used as tablet form

Active Comparator: C. Impaired function, low-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
Drug: Hydrocortisone
used intravenously

Drug: Prednisone
used as tablet form

Active Comparator: D. Impaired function, high-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.
Drug: Hydrocortisone
used intravenously

Drug: Prednisone
used as tablet form




Primary Outcome Measures :
  1. Change from baseline plasma cortisol level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    Plasma cortisol at 8:00, 16:00, 24:00 respectively

  2. Change from baseline plasma ACTH level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    ACTH at 8:00;

  3. Change from baseline 24-hour urine free cortisol [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    24-hour urine free cortisol

  4. Change from baseline insulin tolerance test result [ Time Frame: 7, 30, 90 days post-op ]
    insulin tolerance test result


Secondary Outcome Measures :
  1. Change from baseline plasma TSH level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    plasma TSH level

  2. Sodium, potassium concentration in the blood and urine [ Time Frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days ]
    Concentration of sodium, potassium in the blood and urine

  3. Number of patients with postoperative infection [ Time Frame: For the duration of hospital stay, an expected average of 7 days ]
    Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.

  4. Change from baseline health-related quality of life [ Time Frame: 7, 30, 90 days post-op ]
    The 15-Dimensions measure of health-related quality of life

  5. Number of patients with recurred tumor [ Time Frame: 3,6,12 months after surgery ]
    Enhanced MRI scan of the sellar region.

  6. Change from baseline plasma free T3 level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    plasma free T3 level

  7. Change from baseline plasma free T4 level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    plasma free T4 level

  8. Urine output [ Time Frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days ]
    24-hour urine output



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18
  • Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma)

Exclusion Criteria:

  • Patients with pre-existing hyperthyroidism or Cushing's syndrome
  • Patients with long-term glucocorticoids replacement history
  • Patients with other co-morbidities that pose known influence upon the HPA-axis function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy)
  • Patients with severe panhypopituitarism
  • Patients with history of radiotherapy of the pituitary gland

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190994


Contacts
Layout table for location contacts
Contact: Senlin Yin, M.D. +86 13072808795 enforest@gmail.com

Locations
Layout table for location information
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Senlin Yin, M.D.    +86 13072808795    enforest@gmail.com   
Principal Investigator: Shu Jiang, M.D.         
Sub-Investigator: Senlin Yin, M.D.         
Sub-Investigator: Peizhi Zhou, M.D.         
Sponsors and Collaborators
West China Hospital
Investigators
Layout table for investigator information
Principal Investigator: Shu Jiang, M.D. West China Hospital, Sichuan University, Chengdu, Sichuan, PR China

Layout table for additonal information
Responsible Party: Shu Jiang, Professor Shu Jiang, West China Hospital
ClinicalTrials.gov Identifier: NCT02190994     History of Changes
Other Study ID Numbers: WestChina-2013137
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by Shu Jiang, West China Hospital:
Hydrocortisone
Pituitary adenomas
Replacement therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Craniopharyngioma
Adamantinoma
Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Endocrine Gland Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Prednisone
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Glucocorticoids