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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000845437
• Date of registration: 28/06/2016
• Prospective Registration: No
• Primary sponsor: Tanka Prasad Bohara
• 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
• Date of first enrolment: 19/04/2016
• Target sample size: 122
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616000845437.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Convenience sample;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Nepal

Contacts

• Name: Dr Tanka Prasad Bohara

• Name: Dr Tanka Prasad Bohara

Key inclusion & exclusion criteria

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.
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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Surgery - Other surgery

Post operative sepsis;
Post operative sepsis

Intervention(s)

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.

Primary Outcome(s)

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

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

Secondary Outcome(s)

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.

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

Secondary ID(s)

None

Source(s) of Monetary Support

Tanka Prasad Bohara

Secondary Sponsor(s)

Uttam Laudari

Ethics review

Status: Approved
Approval date:
Contact:

Kathmandu Medical College Public Ltd. Institutional Review Committee