Category: Adrenal Disorders

SOLUMEDROL TREAMENT FOR SEVERE SEPSIS IN HUMANS WITH A BLUNTED ACTH-CORTISOL RESPONSE; A PROSPECTIVE RANDOMINZED DOUBLE BLIND PLACEBO-CONTROLED CLINICAL TRIAL

Monday, Apr 8
1:00 AM – 2:00 AM

Objective : To test the benefits of Solumedrol treatment in sepsis patients with a blunted ACTH-Cortisol response (13 mg/dl) with regards to number of days on ventilator, days on intravenous blood pressure support, length of time in ICU, 14-day and 28-day mortality.  The trial was prospective, randomized and double-blind.


Methods : 124 patients with sepsis had a cortisol response measured. Eleven patients with 0, 30 and 60 min cortisol level < 20 were excluded on suspicion of adrenal insufficency.  Six withdrew consent and 64 with a delta cortisol response > 13 were randomized to Vitamin A or placebo and their data was recently published. Of the 43 patients with a total change in serum cortisol, the "poor ACTH responders", were randomized to steroid or placebo. The poor responders had a baseline cortosol of  32 > 1 mg/dl increased to 38 > 3 mg/dl at 30 min and 40 at 60 minutes.  21 were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive matching intravenous placebo every 8 hours for 7days. There was no significant difference between baseline charateristics in the two randomized groups.  Data analysis was by ANOVA with two tailed test and p < 0.05.


Results : The mean age was 51 (mean SEM) with 61% female. Heart rate (107 vs 107), systolic blood pressure (115 + 5 vs 110 + 4) diastolic blood pressure (59 +3 vs 55 + 3), and temperature (37.8 +0.2 vs 38.1+ 0.3) were similar in the Solumedrol and placebo treated patients at baseline. All cortisol responses were less than 13 mg/dl.  Baseline cortisol levels and response to ACTH were similar in both groups.  Baseline urinary cortisol was measured and found to be similar in Solumedrol and Placebo groups (176 + 23 vs 130 + 26 mcg/gm creatinine) respectively. The number of days in the ICU, number of days on blood pressure agents, number of days on ventilator, serum albumin, creatinine and other lab measurements at day 14 were similar between the Solumedrol and Placebo treated groups.  The 28-day mortality was lower in the Solumedrol group than the placebo treated group (43 + 11 vs 73 +1 0%, p < 0.05).


Discussion :

Patients with sepsis who have a suppressed ACTH-cortisol response (delta < 13 cortisol response), may have clinical benefits when provided high dose short term steriods.  Larger clinical trials should be considered to confirm these data in patients with severe sepsis.


Conclusion :

This small study suggests that 1/3 of patient with sepsis (43 out of 124) have an inability to increase endogenous cortisol levels >13 mg/dl after a 250 mcg ACTH stimulation test.  Providing short term glucocorticoid treatment for 7-days may provide a survival advantage for septic patients with a poor cortisol response to ACTH.

SHORT URL FUNCTION-->

John Tayek

Professor of Medicine-In Residence
David Geffen School of Medicine at UCLA
Torrance, California

Dr. Tayek currently a full time Professor of Medicine at Harbor-UCLA Medical Center and he serves as the Medical Director of Nutrition Day in the USA. He received a Bachelors of Arts Degree from California State University at Fullerton. He received his Masters of Science Degree from Columbia University where he was active in screening physicians for hypercholesterolemia and their risk for heart disease. He received his medical degree from Wayne State University in Detroit Michigan. After an Internal Medicine residency at UCI Medical Center, he received his Clinical Nutrition Fellowship training at New England Deaconess Hospital and Harvard Medical School. He completed a second fellowship in Endocrinology and Metabolism at Harbor-UCLA Medical Center. Dr. Tayek is board certified in Internal Medicine, Endocrinology and Metabolism and in Clinical Nutrition. Dr. Tayek is a full time faculty member at the David Geffen School of Medicine at UCLA. As a full time faculty in the Division of Internal Medicine at the Harbor-UCLA Medical Center, he teaches Nurse Practioners, Medical Students, Residents, Endocrinology Fellows and Junior Faculty.

As a Professor of Medicine-In Residence, he enjoys teaching and interacting closely with the Internal Medicine Residents and the Endocrinology Fellows in training at Harbor-UCLA. Dr. Tayek attends Inpatient Internal Medicine Service, Inpatient Endocrinology Consultation Service and maintains an active Internal Medicine and Endocrinology clinical practice within the managed care community at Harbor-UCLA Medical Center. His clinical interests include Normal and Abnormal Liver Physiology, Diabetes, Hyperlipidemia , Clinical Nutrition, Sepsis and many others areas of Endocrinology. He was been a Principle Investigator on an NIH study of patients with alcoholic hepatitis and cirrhosis (2005-8) and is currently a principle site Investigator on a NIH grant about alcoholic hepatitis. He is also doing a nutritional interventional study with placebo and treated patients with End Stage Renal Failure. His also studying the effects of fish oil treatment on progression of coronary disease in collaboration with Mathew Budoff MD. He is also done research in the field of diabetes mellitus, cardiovascular diseases and renal failure. His earlier NIH funded research also included development of equations to make accurate measurements of liver glucose and amino acid metabolism (NIH K08) in normal humans, diabetics and patients with systemic diseases.

He has published over 55 peer reviewed research article with a focus on liver physiology. He has also published several chapters, and presented over 100 abstracts at national meetings. His interests are in the area of normal and abnormal liver physiology, diabetes and clinical nutrition.

Sajad Hamal

Research Associate
LaBioMedical Research and Education Institute

Research associate who help with data management, data analysis and manuscript preparation. Works full time at LaBioMedical Research Institute.