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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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