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

Primary Purpose

Orthostatic Hypotension, Hemodynamic Instability, Fever

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hydrocortisone High Dose

Hydrocortisone Low Dose

About this trial

This is an interventional prevention trial for Orthostatic Hypotension focused on measuring Corticosteroids, perioperative, colorectal surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cedars Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hydrocortisone High Dose

Hydrocortisone Low Dose

Arm Description

Intervention: 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

Intervention: 1/3 Intravenous equivalent dose (IVED) 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

Outcomes

Primary Outcome Measures

Orthostatic Hypotension

Secondary Outcome Measures

Full Information

NCT ID

NCT01559675

First Posted

March 16, 2012

Last Updated

February 28, 2018

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01559675

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthostatic Hypotension, Hemodynamic Instability, Fever, Hypothermia

Keywords

Corticosteroids, perioperative, colorectal surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrocortisone High Dose

Arm Type

Active Comparator

Arm Description

Arm Title

Hydrocortisone Low Dose

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone High Dose

Other Intervention Name(s)

Solumedrol, Corticosteroid, Steroid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone Low Dose

Other Intervention Name(s)

Solumedrol, Corticosteroid, Steroid

Intervention Description

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

Primary Outcome Measure Information:

Title

Orthostatic Hypotension

Time Frame

Postoperative Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 < 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phillip Fleshner, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23774314

Citation

Zaghiyan K, Melmed GY, Berel D, Ovsepyan G, Murrell Z, Fleshner P. A prospective, randomized, noninferiority trial of steroid dosing after major colorectal surgery. Ann Surg. 2014 Jan;259(1):32-7. doi: 10.1097/SLA.0b013e318297adca.

Results Reference

derived

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

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