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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phillip Fleshner MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01559675
First received: March 16, 2012
Last updated: August 18, 2014
Last verified: August 2014
Results First Received: August 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Orthostatic Hypotension
Hemodynamic Instability
Fever
Hypothermia
Intervention: Drug: Hydrocortisone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between September 2010 and March 2012, 121 patients with 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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
High Dose Steroid

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

Low Dose Steroid

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


Participant Flow:   Overall Study
    High Dose Steroid     Low Dose Steroid  
STARTED     58     63  
COMPLETED     43     49  
NOT COMPLETED     15     14  
Protocol Violation                 1                 2  
2nd operation on same patient excluded                 14                 12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
High Dose Steroid

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

Low Dose Steroid

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

Total Total of all reporting groups

Baseline Measures
    High Dose Steroid     Low Dose Steroid     Total  
Number of Participants  
[units: participants]
  43     49     92  
Age  
[units: years]
Median ( Inter-Quartile Range )
  38  
  ( 24 to 50 )  
  41  
  ( 29 to 50 )  
  40  
  ( 24 to 50 )  
Gender  
[units: participants]
     
Female     21     22     43  
Male     22     27     49  



  Outcome Measures

1.  Primary:   Orthostatic Hypotension   [ Time Frame: Postoperative Day 1 ]

2.  Secondary:   Hemodynamic Instability   [ Time Frame: Through the end of hospitalization or 7 days postoperatively ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Postoperative Nausea   [ Time Frame: Postoperative day 1 - 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Postoperative Fatigue   [ Time Frame: Postoperative day 1 - 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Minor and Major Medical and Surgical Complications   [ Time Frame: Through Postoperative day 30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Length of Postoperative Hospitalization (Days)   [ Time Frame: Duration of hospital stay (expected average of 5 days) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Hemodynamic Instability   [ Time Frame: From time of surgical incision to Postoperative day 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Postoperative Pain   [ Time Frame: Postoperative day 1 - 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: pfleshner@aol.com


No publications provided by Cedars-Sinai Medical Center

Publications automatically indexed to this study:

Responsible Party: Phillip Fleshner MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01559675     History of Changes
Other Study ID Numbers: CSMCSteroidStudy
Study First Received: March 16, 2012
Results First Received: August 18, 2014
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board