Back to results

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

Primary Purpose

Pituitary Neoplasms, Craniopharyngiomas

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Hydrocortisone

Prednisone

About this trial

This is an interventional treatment trial for Pituitary Neoplasms focused on measuring Hydrocortisone, Pituitary adenomas, Replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

West China Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

A. Normal function, non-GC replacement

B. Normal function, low-dose GC

C. Impaired function, low-dose GC

D. Impaired function, high-dose GC

Arm Description

No glucocorticoid replacement will be given perioperatively.

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;

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.

Outcomes

Primary Outcome Measures

Change from baseline plasma cortisol level

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

Change from baseline plasma ACTH level

ACTH at 8:00;

Change from baseline 24-hour urine free cortisol

24-hour urine free cortisol

Change from baseline insulin tolerance test result

insulin tolerance test result

Secondary Outcome Measures

Change from baseline plasma TSH level

plasma TSH level

Sodium, potassium concentration in the blood and urine

Concentration of sodium, potassium in the blood and urine

Number of patients with postoperative infection

Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.

Change from baseline health-related quality of life

The 15-Dimensions measure of health-related quality of life

Number of patients with recurred tumor

Enhanced MRI scan of the sellar region.

Change from baseline plasma free T3 level

plasma free T3 level

Change from baseline plasma free T4 level

plasma free T4 level

Urine output

24-hour urine output

Full Information

NCT ID

NCT02190994

First Posted

July 5, 2014

Last Updated

July 11, 2014

Sponsor

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02190994

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West China Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pituitary Neoplasms, Craniopharyngiomas

Keywords

Hydrocortisone, Pituitary adenomas, Replacement therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A. Normal function, non-GC replacement

Arm Type

No Intervention

Arm Description

No glucocorticoid replacement will be given perioperatively.

Arm Title

B. Normal function, low-dose GC

Arm Type

Active Comparator

Arm Description

Arm Title

C. Impaired function, low-dose GC

Arm Type

Active Comparator

Arm Description

Arm Title

D. Impaired function, high-dose GC

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone

Intervention Description

used intravenously

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

used as tablet form

Primary Outcome Measure Information:

Title

Change from baseline plasma cortisol level

Description

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

Time Frame

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

Title

Change from baseline plasma ACTH level

Description

ACTH at 8:00;

Time Frame

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

Title

Change from baseline 24-hour urine free cortisol

Description

24-hour urine free cortisol

Time Frame

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

Title

Change from baseline insulin tolerance test result

Description

insulin tolerance test result

Time Frame

7, 30, 90 days post-op

Secondary Outcome Measure Information:

Title

Change from baseline plasma TSH level

Description

plasma TSH level

Time Frame

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

Title

Sodium, potassium concentration in the blood and urine

Description

Concentration of sodium, potassium in the blood and urine

Time Frame

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

Title

Number of patients with postoperative infection

Description

Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.

Time Frame

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

Title

Change from baseline health-related quality of life

Description

The 15-Dimensions measure of health-related quality of life

Time Frame

7, 30, 90 days post-op

Title

Number of patients with recurred tumor

Description

Enhanced MRI scan of the sellar region.

Time Frame

3,6,12 months after surgery

Title

Change from baseline plasma free T3 level

Description

plasma free T3 level

Time Frame

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

Title

Change from baseline plasma free T4 level

Description

plasma free T4 level

Time Frame

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

Title

Urine output

Description

24-hour urine output

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Senlin Yin, M.D.

Phone

+86 13072808795

enforest@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shu Jiang, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

West China Hospital, Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Senlin Yin, M.D.

Phone

+86 13072808795

enforest@gmail.com

First Name & Middle Initial & Last Name & Degree

Shu Jiang, M.D.

First Name & Middle Initial & Last Name & Degree

Senlin Yin, M.D.

First Name & Middle Initial & Last Name & Degree

Peizhi Zhou, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs