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

NCT01559675 | Completed Results DMC

• 1 other identifier: CSMCSteroidStudy
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Hypotension; Hemodynamic Instability; Fever; Hypothermia

Keywords

Corticosteroids; perioperative; colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Orthostatic Hypotension

  Postoperative Day 1

Study Arms (2)

Hydrocortisone High Dose

ACTIVE COMPARATOR

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

Drug: Hydrocortisone High Dose

Hydrocortisone Low Dose

EXPERIMENTAL

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

Drug: Hydrocortisone Low Dose

Interventions

Hydrocortisone High Dose DRUG

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

Also known as: Solumedrol, Corticosteroid, Steroid

Hydrocortisone High Dose

Hydrocortisone Low Dose DRUG

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

Also known as: Solumedrol, Corticosteroid, Steroid

Hydrocortisone Low Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• 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.

  PMID: 23774314 DERIVED

MeSH Terms

Conditions

Hypotension, Orthostatic; Fever; Hypothermia

Interventions

Hydrocortisone; Methylprednisolone Hemisuccinate; Adrenal Cortex Hormones; Steroids

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes

Results Point of Contact

• Title: Dr. Phillip Fleshner
• Organization: Cedars Sinai Medical Center

pfleshner@aol.com

310-289-9224

Study Officials

• Phillip Fleshner, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colon & Rectal Surgeon

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 21, 2012
• Study Start: September 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 29, 2018
• Results First Posted: August 29, 2014

Record last verified: 2018-02

Locations

US (1)