N/A
N=121
Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
Orthostatic Hypotension · Hemodynamic Instability · Fever · Hypothermia
Bottom Line
View on ClinicalTrials.gov: NCT01559675 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Orthostatic Hypotension — 2; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrocortisone High Dose (Drug); Hydrocortisone Low Dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Orthostatic Hypotension |
2; 2 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01559675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.