CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled
Drug / intervention
Hydrocortisone High Dose +1 moredrug
Likely dose
Hydrocortisone High Dose 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01559675
NCT01559675N/ACompleted

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

Cedars-Sinai Medical Center·interventional·Posted Mar 21, 2012·Updated Mar 29, 2018

In Brief

A clinical study evaluating Hydrocortisone High Dose and Hydrocortisone Low Dose for Orthostatic Hypotension and 3 related conditions. Completed, enrolled 121 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2012
Enrollment StartSep 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.3 years ago

Interventions

Hydrocortisone High Dosedrug

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

Hydrocortisone Low Dosedrug

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