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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
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Cedars-Sinai Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Phillip Fleshner MD, Colon & Rectal Surgeon, 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

Keywords provided by Cedars-Sinai Medical Center:
Corticosteroids
perioperative
colorectal surgery

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Hypothermia
Autonomic Nervous System Diseases
Body Temperature Changes
Cardiovascular Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Signs and Symptoms
Vascular Diseases
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 20, 2014