Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery - Full Text View

Purpose

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	Intervention
Orthostatic Hypotension Hemodynamic Instability Fever Hypothermia	Drug: Hydrocortisone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Randomized Controlled Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Fever Hypothermia Low Blood Pressure Steroids

Drug Information available for: Hydrocortisone acetate Hydrocortisone Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Hydrocortisone sodium succinate Prednisolone phosphate Hydrocortisone cypionate Prednisolone sodium succinate Methylprednisolone sodium succinate Hydrocortisone butyrate Hydrocortisone valerate Hydrocortisone probutate

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

Orthostatic Hypotension [ Time Frame: Postoperative Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hemodynamic instability [ Time Frame: Through the end of hospitalization or 7 days postoperatively ] [ Designated as safety issue: Yes ]
Postoperative Nausea [ Time Frame: Postoperative day 1 - 7 ] [ Designated as safety issue: No ]
Measured daily Postoperative day 1 - 7 on a scale from 0 (no nausea) to 10 (nausea as bad as can be)
Postoperative fatigue [ Time Frame: Postoperative day 1 - 7 ] [ Designated as safety issue: No ]
Measured daily, score 0 (no fatigue) to 10 (very fatigued)
Minor and Major medical and surgical complications [ Time Frame: Through Postoperative day 30 ] [ Designated as safety issue: Yes ]
Length of postoperative hospitalization (days) [ Time Frame: Duration of hospital stay (expected average of 5 days) ] [ Designated as safety issue: No ]
Hemodynamic instability [ Time Frame: From time of surgical incision to Postoperative day 7 ] [ Designated as safety issue: Yes ]
Hemodynamic instability defined by heart rate >100 bpm, <60 bpm, Systolic blood pressure <90 mm Hg
Postoperative Pain [ Time Frame: Postoperative day 1 - 7 ] [ Designated as safety issue: No ]
Assessed daily by visual analog pain score (0 to 10; no pain to severe)

Enrollment:	121
Study Start Date:	September 2010
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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	Drug: 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 Other Names: Solumedrol Corticosteroid Steroid
Experimental: 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	Drug: 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 Other Names: Solumedrol Corticosteroid Steroid

Arms

Assigned Interventions

Active Comparator: 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

Drug: 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

Other Names:

Solumedrol
Corticosteroid
Steroid

Experimental: 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

Drug: 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

Other Names:

Solumedrol
Corticosteroid
Steroid

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559675

Locations

United States, California
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

More Information

No publications provided

Responsible Party:	Phillip Fleshner MD, Pricipal investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01559675 History of Changes
Other Study ID Numbers:	CSMCSteroidStudy
Study First Received:	March 16, 2012
Last Updated:	August 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

Corticosteroids
perioperative
colorectal surgery

Additional relevant MeSH terms:

Hypotension
Hypotension, Orthostatic
Hypothermia
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Methylprednisolone acetate

Prednisolone acetate
Hydrocortisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Hydrocortisone-17-butyrate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013