Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis

NCT00368381 | Withdrawn Phase 4

• 1 other identifier: 06-05-1813
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if the combination of hydrocortisone plus fludrocortisone is more efficacious than hydrocortisone alone in treating adrenal insufficiency in severe sepsis.

Conditions

Sepsis; Adrenal Insufficiency

Keywords

sepsis; septicemia; sepsis syndrome; adrenal insufficiency; adrenal cortex hormones; hydrocortisone; fludrocortisone

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  All cause mortality during first 28-days after study randomization.

  28 days

Secondary Outcomes (1)

• Intensive care unit survival, duration of intensive care unit stay, duration of hospitalization, survival to hospital discharge, time to vasopressor withdrawal

  Unable to define

Study Arms (1)

Hydrocortision and fludrocortisone

ACTIVE COMPARATOR

Study is comparing hydrocortisone alone versus the combination of hydrocortisone and fludrocortisone in the treatment of adrenal insufficiency of septic patients.

Drug: Hydrocortisone

Interventions

Hydrocortisone DRUG

Patients randomized to this arm will receive hydrocortisone for the treatment of adrenal insufficiency secondary to sepsis.

Hydrocortision and fludrocortisone

Eligibility Criteria

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

You may qualify if:

• Males and non-pregnant females \> 18 years of age
• Patients admitted and/or pending admission to the intensive care unit
• Positive corticotropin stimulation test (Basal cortisol level of ≤ 34 μg/dL with Δ ≤ 9 μg/dL after administration of 250 mg of cosyntropin)
• Patient satisfies criteria for severe sepsis Infection - one or more of the following criteria
• Documented or Suspected - positive culture results (from blood, sputum, urine, etc.)
• Anti-Infective Therapy - patient is receiving antibiotic, antifungal, or other anti-infective therapy
• Pneumonia - documentation of pneumonia (x-ray, etc.)
• WBCs - WBCs found in normally sterile .uid (urine, CSF, etc.)
• Perforated Viscus - perforation of hollow organ (bowel)
• SIRS - two or more of the following
• Temperature \> 38° or \< 36°
• Heart rate \> 90 bpm
• Respiratory rate above 20 breaths per minute
• WBC \> 14,000/mm3 , \< 4000/mm3, or \>10% Bands
• Acute organ dysfunction - one or more of the following

You may not qualify if:

• Patients who respond to the short cosyntropin stimulation test(Δ \> 9mg/dL)
• Pregnancy or breast-feeding mother
• Evidence of acute myocardial infarction, meningitis, pulmonary embolism
• AIDS (CD4 \< 200 cells/mL)
• Contraindications for corticosteroids
• Formal indication for corticosteroids (specifically including patients with known adrenal insufficiency)
• Onset of shock \> 24 hours
• Etomidate administration within the 6 hours preceding randomization
• Cardiac arrest prior to randomization.

Sponsors & Collaborators

• CAMC Health System: lead

Related Publications (27)

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MeSH Terms

Conditions

Sepsis; Adrenal Insufficiency; Systemic Inflammatory Response Syndrome

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenal Gland Diseases; Endocrine System Diseases; Shock

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• John A Bethea, Pharm.D.

  Charleston Area Medical Center (CAMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist, Trauma/Surgery

Study Record Dates

• First Submitted: August 23, 2006
• First Posted: August 24, 2006
• Study Start: September 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 13, 2012

Record last verified: 2012-02