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

NCT02190994 | Unknown Phase 4

• 1 other identifier: WestChina-2013137
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Neoplasms; Craniopharyngiomas

Keywords

Hydrocortisone; Pituitary adenomas; Replacement therapy

Outcome Measures

Primary Outcomes (4)

• Change from baseline plasma cortisol level

  Plasma cortisol at 8:00, 16:00, 24:00 respectively

  1, 3, 5, 7, 30, 90, 180, 360 days post-op

• Change from baseline plasma ACTH level

  ACTH at 8:00;

  1, 3, 5, 7, 30, 90, 180, 360 days post-op

• Change from baseline 24-hour urine free cortisol

  24-hour urine free cortisol

  1, 3, 5, 7, 30, 90, 180, 360 days post-op

• Change from baseline insulin tolerance test result

  insulin tolerance test result

  7, 30, 90 days post-op

Secondary Outcomes (8)

• Change from baseline plasma TSH level

  1, 3, 5, 7, 30, 90, 180, 360 days post-op

• Sodium, potassium concentration in the blood and urine

  Daily post-op,for the duration of hospital stay, an expected average of 7 days

• Number of patients with postoperative infection

  For the duration of hospital stay, an expected average of 7 days

• Change from baseline health-related quality of life

  7, 30, 90 days post-op

• Number of patients with recurred tumor

  3,6,12 months after surgery

Study Arms (4)

A. Normal function, non-GC replacement

NO INTERVENTION

No glucocorticoid replacement will be given perioperatively.

B. Normal function, low-dose GC

ACTIVE COMPARATOR

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; Drug: Prednisone

C. Impaired function, low-dose GC

ACTIVE COMPARATOR

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; Drug: Prednisone

D. Impaired function, high-dose GC

ACTIVE COMPARATOR

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; Drug: Prednisone

Interventions

Hydrocortisone DRUG

used intravenously

B. Normal function, low-dose GC; C. Impaired function, low-dose GC; D. Impaired function, high-dose GC

Prednisone DRUG

used as tablet form

B. Normal function, low-dose GC; C. Impaired function, low-dose GC; D. Impaired function, high-dose GC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms; Craniopharyngioma

Interventions

Hydrocortisone; Prednisone

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienediols; Pregnadienes

Study Officials

• Shu Jiang, M.D.

  West China Hospital, Sichuan University, Chengdu, Sichuan, PR China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senlin Yin, M.D.

CONTACT

+86 13072808795; enforest@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Shu Jiang

Study Record Dates

• First Submitted: July 5, 2014
• First Posted: July 15, 2014
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

CN (1)