ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000845437

Ethics application status

Approved

Date submitted

24/04/2016

Date registered

28/06/2016

Date last updated

28/06/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Role of Neutrophil Lymphocyte Ratio in Early Detection of Septic Complications After Major Operations

Scientific title

Role of Neutrophil Lymphocyte Ratio in Early Detection of Septic Complications After Major Operations

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1180-7385

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post operative sepsis

Condition category

Condition code

Surgery

Other surgery

Infection

Other infectious diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Patients undergoing major operations that require post-operative intensive care unit care will be observed for development of postoperative sepsis.
Routine blood investigations are sent daily in the intensive care unit. We will calculate neutrophil-lymphocyte count from the complete blood count sent as a routine investigation. We will calculate neutrophil lymphocyte ratio on post-operative day 1 and day 2 and follow up the participants till discharge from the hospital.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Postoperative sepsis
Post-operative sepsis will be defined as per ACCP/SCCM guidelines.
Sepsis The systemic response to infection, manifested by two or more of the following conditions: (1) temperature >38 degree Celsius or <36 degree Celsius (2;) heart rate >90 beats per minute; (3) respiratory rate >20 breaths per minute or PaCO2, <32 mm Hg; and (4) white blood cell count >12,000/cu mm, <4,000/cu mm, or >10% immature (band) forms.

All patients with suspected sepsis will be worked up to identify the source of sepsis with chest x-ray, sputum gram stain and culture sensitivity (if Chest X-ray is suggestive of pneumonia), urinary routine and culture sensitivity,ultrasound / computed tomography and other investigations will be done if clinically indicated Urinary tract infection will be diagnosed based on presence of pus cell >3 0r more White blood cell in unspun urine sample in microscopic examination and/or positive urine culture. Pneumonia will be diagnosed if the chest x-ray shows infiltrate and/or presence of pus cells in gram’s stain and positive sputum culture. Abscess or peritonitis will be diagnosed based on clinical and radiological examination

Reference
Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. 1992. Chest. 2009 Nov;136(5 Suppl):e28

Timepoint [1]

The patient will be assessed daily till the time of discharge from ICU.

Primary outcome [2]

Neutrophil Lymphocyte Ratio will be calculated as ratio of Neutrophil to Lymphocyte count.
The value of this ratio will be compared between the groups of patient with and without postoperative sepsis.

Timepoint [2]

Neutrophil Lymphocyte Ratio will be calculated on the postoperative day 1 and 2.

Secondary outcome [1]

SIRS without sepsis
SIRS will be defined as per ACCP/SCCM guidelines.
Systemic inflammatory response syndrome (SIRS) The systemic inflammatory response to a variety of severe clinical insults. The response is manifested by two or more of the following conditions:
(1) temperature >38 degree Celsius or <36 Celsius C(2;) heart rate >90 beats per minute; (3) respiratory rate >20 breaths per minute or PaCO2, <32 mm Hg; and (4) white blood cell count >12,000/cu mm, <4,000/cu mm, or >10% immature (band) forms.

Timepoint [1]

The patient will be assessed daily till the time of discharge from ICU.

Eligibility

Key inclusion criteria

Patients undergoing major operations requiring intensive care unit admission postoperatively.
Operations involving opening of the body cavities will be considered as major operations. Operations involving abdomen and chest will be included in this study.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients undergoing emergency operations
Pre- operative use of anti-inflammatory drugs
Pre-operative use of chemotherapy and steroids
Patients with haematological malignancy
Patient not giving consent for the study

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Statistical analysis will be performed using SPSS software(version 20.0, SPSS Inc., Chicago, IL). Data for the clinical characteristics of patients will be expressed as median(25th–75th percentile). The clinical characteristics of the patients will be compared using the chi-square test or the Mann–Whitney U-test according to the variable type and the data distribution. The Mann–Whitney U-test will be performed for two independent groups. The Wilcoxon signed-rank test will be performed for intragroup changes. P<0.05 will be considered to be significant.The accuracy of NLR in the prediction of postoperative septic complications will be assessed by comparing the area under the receiver operating characteristic curve (AUC-ROC).

n=Z^2(pq )/ e^2 = 122
Z=1.96 prevalence in reference study (p)= 8.7% q= 1- p= 91.3% error(e)= 5 %
Above formula of sample calculation was used to determine the sample size. In reference study prevalence of post operative sepsis is 8.7%.
Level of statistical significane = 5%
Effect size = 20%
Power = 1- beta Beta = 20%
Power= 1- 20%=80%

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

19/04/2016

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

122

Accrual to date

Final

Recruitment outside Australia

Country [1]

Nepal

State/province [1]

Bagmati

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Tanka Prasad Bohara

Address [1]

Department of Surgery
Kathmandu Medical College Teaching Hospital
184, Babu Ram Acharya Sadak
Sinamangal
Kathmandu
Nepal
44600

Country [1]

Nepal

Primary sponsor type

Individual

Name

Tanka Prasad Bohara

Address

Department of Surgery
Kathmandu Medical College Teaching Hospital
184, Babu Ram Acharya Sadak
Sinamangal
Kathmandu
Nepal
44600

Country

Nepal

Secondary sponsor category [1]

Individual

Name [1]

Uttam Laudari

Address [1]

Department of Surgery
Kathmandu Medical College Teaching Hospital
184, Babu Ram Acharya Sadak
Sinamangal
Kathmandu
Nepal
44600

Country [1]

Nepal

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Kathmandu Medical College Public Ltd. Institutional Review Committee

Ethics committee address [1]

Kathmandu Medical College
Institutional Review Committee
PO Box 21266
Kathmandu Medical College Teaching Hospital
184, Babu Ram Acharya Sadak
Sinamangal
Kathmandu
Nepal
44600

Ethics committee country [1]

Nepal

Date submitted for ethics approval [1]

03/03/2016

Approval date [1]

08/04/2016

Ethics approval number [1]

08042016

Summary

Brief summary

Recent advances in medical and surgical techniques with a better understanding of the pathophysiology of disease condition have made operations safe. However, post-operative sepsis remains a dreaded complication. Early identification and prompt treatment have shown to be effective in decreasing morbidity and mortality associated with septic complications. 
Various biochemical markers such as serum lactate level, interleukin 6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP)etc have shown to be early markers of subsequent post-operative sepsis. But these investigations are not universally available and are relatively expensive. These limits their use most of the centres. Recently there has been interest in Neutrophil Lymphocyte ratio (NLR) as a marker of inflammation and its clinical use as a septic marker. 
Zahorec et al studied 90 oncological patients who had undergone elective, emergency operations and medical intensive care patients treated for severe sepsis and septic shock. They showed a correlation between the severity of clinical course grades of neutrophilia and lymphocytopenia. They suggested that the term Neutrophil-lymphocyte stress factor which is a ratio of neutrophil to lymphocyte counts.
Since then NLR has been used and studied in various clinical settings such as bacteremia, sepsis, acute pancreatitis, and acute cholecystitis, prognostic markers in esophageal and colonic malignancy. NLR has also been used as a surrogate marker of resectability in patients with pancreatic adenocarcinoma. NLR has also been studied in cardiovascular patients
 and patients undergoing coronary artery bypass graft as a prognostic marker. 
P. G. Vaughan-Shaw et al  studied C-reactive protein (CRP) and NLR in outcome prediction after emergency abdominal surgery in the elderly patients. They used mortality at 30 days, 6 months and 12 months as end points. They identified NLR to be an independent predictor of 30-day outcome in multivariate analysis. Gurol et al studied NLR and compared with PCT level to identify the NLR cut off for bacteremia by using PCT as a reference. They found a positive correlation between PCT and NLR (0.2582, p<0.001). They suggested the cut-off value of = 5 as the marker of bacteremia and sepsis.
Though NLR has been studied in various clinical settings it has not been studied as the marker of postoperative sepsis. The aim of this study is to investigate the role of NLR as an early predictor of postoperative septic complications.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tanka Prasad Bohara

Address

Department of Surgery
Kathmandu Medical College Teaching Hospital
184, Babu Ram Acharya Sadak
Sinamangal
Kathmandu
Nepal
44600

Country

Nepal

Phone

+9779841352378

Fax

tankaprasad.bohara@gmail.com

Contact person for public queries

Name

Tanka Prasad Bohara

Address

Department of Surgery
Kathmandu Medical College Teaching Hospital
184, Babu Ram Acharya Sadak
Sinamangal
Kathmandu
Nepal
44600

Country

Nepal

Phone

+9779841352378

Fax

tankaprasad.bohara@gmail.com

Contact person for scientific queries

Name

Tanka Prasad Bohara

Address

Department of Surgery
Kathmandu Medical College Teaching Hospital
184, Babu Ram Acharya Sadak
Sinamangal
Kathmandu
Nepal
44600

Country

Nepal

Phone

+9779841352378

Fax

tankaprasad.bohara@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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