search
Back to results

Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery

Primary Purpose

Systemic Inflammatory Response Syndrome, Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Hydrocortisone
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Inflammatory Response Syndrome focused on measuring Cardiac surgery, systemic inflammatory response syndrome, health-related quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min

Exclusion Criteria:

  • Pregnancy
  • Severe liver insufficiency
  • Severe renal insufficiency
  • Insulin dependent diabetes mellitus
  • Steroid therapy
  • Psychiatric disease

Sites / Locations

  • Department of Anesthesiology, University of Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

Arm Description

Stress doses of hydrocortisone

Outcomes

Primary Outcome Measures

immunologic markers, health care related quality of life, PTSD

Secondary Outcome Measures

early clinical outcome parameters (LOS in the ICU)

Full Information

First Posted
June 21, 2007
Last Updated
September 2, 2008
Sponsor
Ludwig-Maximilians - University of Munich
search

1. Study Identification

Unique Protocol Identification Number
NCT00490828
Brief Title
Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery
Official Title
Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory action. In this prospective interventional study this hypothesis is to be proven.
Detailed Description
Methods: Prospective interventional randomized double blind placebo controlled study. Intervention: Hydrocortisone in stress doses vs. placebo Patients: 92 high risk patients after cardiac surgery Measurements: Cytokines, Toll-like receptors, NF kappa B, outcome data, health care related quality of life, PTSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Posttraumatic Stress Disorder
Keywords
Cardiac surgery, systemic inflammatory response syndrome, health-related quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Arm Description
Stress doses of hydrocortisone
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
Stress doses of hydrocortisone
Intervention Description
Hydrocortisone
Primary Outcome Measure Information:
Title
immunologic markers, health care related quality of life, PTSD
Time Frame
one and a half year
Secondary Outcome Measure Information:
Title
early clinical outcome parameters (LOS in the ICU)
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min Exclusion Criteria: Pregnancy Severe liver insufficiency Severe renal insufficiency Insulin dependent diabetes mellitus Steroid therapy Psychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shananz Azad, M.D.
Organizational Affiliation
Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, University of Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33045104
Citation
Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.
Results Reference
derived
PubMed Identifier
23006898
Citation
Hauer D, Weis F, Campolongo P, Schopp M, Beiras-Fernandez A, Strewe C, Giehl M, Toth R, Kilger E, Schelling G. Glucocorticoid-endocannabinoid interaction in cardiac surgical patients: relationship to early cognitive dysfunction and late depression. Rev Neurosci. 2012;23(5-6):681-90. doi: 10.1515/revneuro-2012-0058.
Results Reference
derived

Learn more about this trial

Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery

We'll reach out to this number within 24 hrs