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Trial record 2 of 2 for:    "Orthostatic Intolerance" | "Prednisolone phosphate"

Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT01559675
Recruitment Status : Completed
First Posted : March 21, 2012
Results First Posted : August 29, 2014
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Phillip Fleshner MD, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Orthostatic Hypotension
Hemodynamic Instability
Fever
Hypothermia
Interventions Drug: Hydrocortisone High Dose
Drug: Hydrocortisone Low Dose
Enrollment 121
Recruitment Details Between September 2010 and March 2012, 121 patients with Inflammatory bowel disease (IBD) between the ages of 18 to 75 years taking corticosteroids, or previously treated with steroids within the previous 1 year, undergoing major colorectal surgery by a single surgeon at a single institution were recruited for this study
Pre-assignment Details Of 258 patients assessed for eligibility, 137did not meet inclusion criteria. 9 patients refused to participate. 121 were then randomized to one of 2 study arms
Arm/Group Title High Dose Steroid Low Dose Steroid
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Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

Period Title: Overall Study
Started 58 63
Completed 43 49
Not Completed 15 14
Reason Not Completed
Protocol Violation             1             2
2nd operation on same patient excluded             14             12
Arm/Group Title High Dose Steroid Low Dose Steroid Total
Hide Arm/Group Description

Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

Total of all reporting groups
Overall Number of Baseline Participants 43 49 92
Hide Baseline Analysis Population Description
We assumed that patients treated with HDS would have no postural hypotension on POD1 95% of the time. The noninferiority margin was 10%. We calculated that a sample size of 118 patients (59 patients per study arm) was needed to establish clinical equivalency with a 1-sided α level of 0.05 and 80% power.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 43 participants 49 participants 92 participants
38
(24 to 50)
41
(29 to 50)
40
(24 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 49 participants 92 participants
Female
21
  48.8%
22
  44.9%
43
  46.7%
Male
22
  51.2%
27
  55.1%
49
  53.3%
1.Primary Outcome
Title Orthostatic Hypotension
Hide Description [Not Specified]
Time Frame Postoperative Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Steroid Low Dose Steroid
Hide Arm/Group Description:

Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

Overall Number of Participants Analyzed 43 49
Measure Type: Number
Unit of Measure: participants
2 2
Time Frame adverse events were collected for the 30-day postoperative period.
Adverse Event Reporting Description adverse events were identified through patient chart review, reporting by investigators, and at the time of patient follow up for postoperative followup and phone call at 30 days
 
Arm/Group Title High Dose Steroid Low Dose Steroid
Hide Arm/Group Description

Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed

All-Cause Mortality
High Dose Steroid Low Dose Steroid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Steroid Low Dose Steroid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose Steroid Low Dose Steroid
Affected / at Risk (%) Affected / at Risk (%)
Total   11/43 (25.58%)   12/49 (24.49%) 
Cardiac disorders     
Major Medical complication   3/43 (6.98%)  2/49 (4.08%) 
Gastrointestinal disorders     
Minor surgical complication   2/43 (4.65%)  3/49 (6.12%) 
Major surgical complication   6/43 (13.95%)  7/49 (14.29%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Phillip Fleshner
Organization: Cedars Sinai Medical Center
Phone: 310-289-9224
Responsible Party: Phillip Fleshner MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01559675     History of Changes
Other Study ID Numbers: CSMCSteroidStudy
First Submitted: March 16, 2012
First Posted: March 21, 2012
Results First Submitted: August 18, 2014
Results First Posted: August 29, 2014
Last Update Posted: March 29, 2018