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Hs-CRP and NLR as Markers of Perioperative Stress

Sponsor
Ufuk University (Other)
Overall Status
Completed
CT.gov ID
NCT03594695
Collaborator
(none)
70
Enrollment
1
Location
1
Actual Duration (Months)
68.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Jul 20, 2018
Actual Primary Completion Date :
Aug 15, 2018
Actual Study Completion Date :
Aug 20, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the change in HSCRP levels [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ufuk University Ankara Balgat Turkey 06520

Sponsors and Collaborators

  • Ufuk University

Investigators

  • Principal Investigator: Hakan Yılmaz, MD, UFUK UNIVERSITY FACULTY OF MEDICINE

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hakan Yılmaz, Assoc Prof, Ufuk University
ClinicalTrials.gov Identifier:
NCT03594695
Other Study ID Numbers:
  • hsCRP
First Posted:
Jul 20, 2018
Last Update Posted:
Oct 15, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
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, Assoc Prof, Ufuk University
cesarean section, anesthesia, hs-CRP, NLR

Study Results

No Results Posted as of Oct 15, 2018