Steroid-induced reduction of surgical stress

Steroid-induced reduction of surgical stress - StReSS StTudy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32372

Enrollment

108

Registered

2008-11-27

Start date

2009-06-24

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CABG coronary bypass surgery

Interventions

0.05 ml/kg dexamethason, i.v. (20 mg/ml, clear fluid) or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients undergoing coronary artery bypass surgery (CABG) Use of cardiopulmonary bypass (CPB) Age 18-75 years Informed consent

Exclusion criteria

Exclusion criteria: Re-operations Emergency operation Body surface area (BSA) 1.7 > BSA

Design outcomes

Primary

Measure	Time frame
Expression of p38 in cultured cells and cardiac tissue	—

Secondary

Measure	Time frame
Pro-apoptotic signaling in atrial biopsies and cultured cells Blood will be sampled for the measurement of Tumor Necrosis Factor-alpha (TNF-*), IL-6, IL-8, IL-10 and IL-4 and CRP before induction of anesthesia and at the end of surgery. Plasma samples will be investigated for the presence of novel biomarkers: precursor peptides of ANP (proANP), vasopressin (Copeptin), Endothelin-1 (proET-1) and Adrenomedullin (proADM). Demographic variables: Age, gender, length, body weight, preoperative and postoperative hematocrit, hemoglobin, leukocyte count. Surgical characteristics: Surgery time, clamp time, CPB time	—

Measure

Time frame

Pro-apoptotic signaling in atrial biopsies and cultured cells Blood will be sampled for the measurement of Tumor Necrosis Factor-alpha (TNF-*), IL-6, IL-8, IL-10 and IL-4 and CRP before induction of anesthesia and at the end of surgery. Plasma samples will be investigated for the presence of novel biomarkers: precursor peptides of ANP (proANP), vasopressin (Copeptin), Endothelin-1 (proET-1) and Adrenomedullin (proADM). Demographic variables: Age, gender, length, body weight, preoperative and postoperative hematocrit, hemoglobin, leukocyte count. Surgical characteristics: Surgery time, clamp time, CPB time

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)