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Hs-CRP and NLR as Markers of Perioperative Stress

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ClinicalTrials.gov Identifier: NCT03594695
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Hakan Yılmaz, Ufuk University

Brief Summary:
The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).

Condition or disease Intervention/treatment
Cesarean Delivery Affecting Newborn Anesthesia Inflammatory Response Diagnostic Test: HSCRP and NLR

Detailed Description:
The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response. Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The degree of systemic inflammation has been determined by numerous pro- and anti-inflammatory cytokines.The cytokines control the release of C -reactive protein (CRP) which is an acute phase reactant produced by the liver. CRP is a widely used marker of inflammation and tissue damage. High sensitive C -reactive protein (hs-CRP), is a more sensitive assay for detection of inflammation measured by particle-enhanced immunonephelometry . A rapid increase in hs-CRP may indicate inflammation and tissue damage . Another well-known indicator of inflammation is neutrophil-to-lymphocyte ratio (NLR). NLR correlates strongly with elevated plasma levels of circulating proinflammatory cytokineS. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Hs-CRP and NLR as Markers of Perioperative Stress in Maternal And Fetal Blood in Different Anesthesia Techniques
Actual Study Start Date : July 20, 2018
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 20, 2018

Group/Cohort Intervention/treatment
Group G
Patients undergoing general anesthesia HSCRP and NLR measurement
Diagnostic Test: HSCRP and NLR
hs-CRP levels and NLR values will be studied from routine blood samples.

Group R
Patients undergoing spinal anesthesia HSCRP and NLR measurement
Diagnostic Test: HSCRP and NLR
hs-CRP levels and NLR values will be studied from routine blood samples.




Primary Outcome Measures :
  1. Evaluation of the change in HSCRP levels [ Time Frame: preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery) ]
    Measurement of high sensitive C reactive protein levels in different time points in order to evaluate the change in HSCRP levels

  2. Evaluation of the change in NLR [ Time Frame: preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery) ]
    Measurement of the Neutrophil to Lymphocyte Ratio in different time points in order to evaluate the change in the Neutrophil to Lymphocyte Ratios



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This observational study is conducted in cesarean sections
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is composed of healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy).
Criteria

Inclusion Criteria:

  • Healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy)

Exclusion Criteria:

  • refusal to participate,
  • chronic diseases (diabetes mellitus, hypertension, heart disease, renal disease, hypo/hyperthyroidism)
  • any infections,
  • smoking
  • contraindications for central neuraxial anesthesia.
  • Pregnancies complicated with rupture of membranes, placenta previa, eclampsia/preeclampsia, and abruptio placenta
  • fetal anomalies,
  • abnormality detected at fetal well-being tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594695


Locations
Turkey
Ufuk University
Ankara, Balgat, Turkey, 06520
Sponsors and Collaborators
Ufuk University
Investigators
Principal Investigator: Hakan Yılmaz, MD UFUK UNIVERSITY FACULTY OF MEDICINE

Publications:
Responsible Party: Hakan Yılmaz, Assoc Prof, Ufuk University
ClinicalTrials.gov Identifier: NCT03594695     History of Changes
Other Study ID Numbers: hsCRP
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hakan Yılmaz, Ufuk University:
cesarean section, anesthesia, hs-CRP, NLR

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs