Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
Condition: Orthostatic Hypotension; Hemodynamic Instability; Fever; Hypothermia
MeSH terms: Hypotension, Orthostatic; Hypotension; Hypothermia
Study type: Interventional

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.
    

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.
    

Intervention name(s): Hydrocortisone High Dose; Hydrocortisone Low Dose
Intervention type(s): Drug; Drug
Intervention description(s): 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 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 intervention name(s): Solumedrol; Corticosteroid; Steroid; Solumedrol; Corticosteroid; Steroid
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methylprednisolone Hemisuccinate; Methylprednisolone Acetate; Methylprednisolone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Corticosteroids; perioperative; colorectal surgery