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

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01559675
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of low dose versus high dose steroids vital signs of patients currently on steroids or recently treated with steroids undergoing major colorectal surgery. The investigators hypothesize that there will be no statistically significant difference in orthostatic hypotension (blood pressure measured on lying, sitting, and standing), blood pressure, temperature or heart rate in the standard and low dose groups.

Condition or Disease	Intervention/Treatment	Phase
Orthostatic Hypotension; Hemodynamic Instability; Fever; Hypothermia	Drug: Hydrocortisone High Dose; Drug: Hydrocortisone Low Dose	N/A

Detailed Description

Our primary aim is to study the perioperative hemodynamic profile of patients on chronic steroids undergoing colon and rectal surgery. We will do this by measuring heart rate, temperature and blood pressure in the operating room and during their postoperative hospitalization. Patients will be identified in their preoperative visit. They will be randomized to high dose and low dose steroid study groups. The standard dose steroid patients will receive hydrocortisone 100 mg IV preoperatively and 100 mg IV every 8 hrs with standard taper. The low dose steroid study group will receive the IV equivalent of their preoperative steroid dose in the postoperative period. The patients blood pressure, temperature and heart rate will be monitored in the operating room and the ward postoperatively. Outcomes will be compared between the two groups. We hypothesize that there will be no statistically significant difference in blood pressure, temperature or heart rate in the high dose and low dose groups.

The secondary aim of this study will be monitoring of any differences in surgical outcomes, including postoperative length of stay, between the two patient groups.

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Controlled Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hydrocortisone High Dose Intervention: 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	Drug: Hydrocortisone High Dose; 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; Other Names: Solumedrol Corticosteroid Steroid
Experimental: Hydrocortisone Low Dose Intervention: 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	Drug: Hydrocortisone Low Dose; 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; Other Names: Solumedrol Corticosteroid Steroid

Outcome Measures

Primary Outcome Measures

1. Orthostatic Hypotension [Postoperative Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• History of ulcerative colitis, inflammatory bowel disease unclassified, indeterminate colitis, or Crohn's disease;

• Major colorectal surgery, defined as surgery requiring an abdominal incision. Both open and laparoscopic procedures are eligible. Urgent and elective procedures are eligible;

• Corticosteroid therapy within 12 months of surgery;

• Able and willing to comply with all protocol procedures for the planned duration of the study

• Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information.

Exclusion Criteria:

• Patients with hypotension (systolic < 90 mm Hg or diastolic < 50 mm Hg) in the preoperative area

• Patients having emergency surgery

• Children < 18 or adults > 75 years of age

• Pregnant patients

• Patients who have suffered prior hemodynamic complications of steroid withdrawal

• Other major physical or major psychiatric illness, including alcohol or substance addiction, within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial.

• Any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety or efficacy of the different steroid doses according to the study protocol

• Patients on steroids without inflammatory bowel disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Phillip Fleshner, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phillip Fleshner MD, Colon & Rectal Surgeon, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT01559675
• Other Study ID Numbers: CSMCSteroidStudy
• First Posted: Mar 21, 2012
• Last Update Posted: Mar 29, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Phillip Fleshner MD, Colon & Rectal Surgeon, Cedars-Sinai Medical Center: Corticosteroids; perioperative; colorectal surgery
• Additional relevant MeSH terms: Hypotension, Orthostatic; Hypotension; Hypothermia; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methylprednisolone Hemisuccinate; Methylprednisolone Acetate; Methylprednisolone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

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 Detail	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
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 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

Baseline Characteristics

Arm/Group Title	High Dose Steroid	Low Dose Steroid	Total
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 Participants	43	49	92
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	38	41	40
Sex: Female, Male (Count of Participants)
Female	21 48.8%	22 44.9%	43 46.7%
Male	22 51.2%	27 55.1%	49 53.3%

Outcome Measures

1. Primary Outcome

Title	Orthostatic Hypotension
Time Frame	Postoperative Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Dose Steroid	Low Dose Steroid
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
Measure Participants	43	49
Number [participants]	2 4.7%	2 4.1%

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	High Dose Steroid		Low Dose Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	High Dose Steroid		Low Dose Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/43 (25.6%)		12/49 (24.5%)
Cardiac disorders
Major Medical complication	3/43 (7%)		2/49 (4.1%)
Gastrointestinal disorders
Minor surgical complication	2/43 (4.7%)		3/49 (6.1%)
Major surgical complication	6/43 (14%)		7/49 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

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.