Hs-CRP and NLR as Markers of Perioperative Stress

October 12, 2018 updated by: Hakan Yılmaz, Ufuk University

Hs-CRP and NLR as Markers of Perioperative Stress in Maternal And Fetal Blood in Different Anesthesia Techniques

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Balgat
      • Ankara, Balgat, Turkey, 06520
        • UfUK UNIVERSITY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)
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
preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ufuk University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2018

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 20, 2018

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • hsCRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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