Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis.

April 30, 2023 updated by: Mohamed Hamed Mohamed, Sohag University

Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis

Spontaneous bacterial peritonitis (SBP) is a serious complication of ascites that can lead to death and can be described as an acute infection of ascites without any certain source of infection SBP is considered the most common infection in cirrhotic patients with ascites. SBP is diagnosed by the presence of ≥250 polymorphonuclear leukocyte (PMNL)/mm3 in the ascetic fluid in absence of surgical and treatable causes of intra-abdominal infections .

SBP has many pictures of clinical presentation SBP can be asymptomatic and patients pass unnoticed or can discovered accidentally may have local symptoms and signs of peritonitis such as abdominal pain, and tachypnea or may present with signs of deteriorated liver function in form of gastrointestinal bleeding, shock and renal failure An increasing amount of studies have demonstrated that peripheral blood neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR) are indicators of systematic inflammatory response and are widely investigated as useful predictors of the clinical outcomes in various diseases .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Observational

Enrollment (Anticipated)

Enrollment

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300

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Asmaa N Mohamed

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Asses the value of blood platelets to lymphocytes ratio and monocytes to lymphocytes ratio as predictors of response for the treatment of spontaneous bacterial peritonitis in cirrhotic patients.

Description

Inclusion Criteria:

  • Cirrhotic patient with ascites.
  • Un treated SBP

Exclusion Criteria:

  • Ascites without cirrhosis (malignant ascites, chylous ascites, etc…).
  • Tuberculous peritonitis.
  • Secondary bacterial peritonitis due to any surgical cause.
  • Sepsis rather than SBP.
  • Patients with unrelated infections e.g. skin, chest infection, etc.
  • Patients started treatment of SBP.
  • Patients on prophylactic antibiotics for recurrent SBP prevention .
  • Patients declining to provide informed consent.
  • Patients with hepatocellular carcinoma on top of cirrhosis.
  • Patients with other malignancy or any immunological disease

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cirrhotic Patients with Spontaneous Bacterial Peritonitis
Diagnostic test: ascetic fluid study
ascetic fluid study parameter in diagnosis of spontaneous bacterial peritpnitis
patient liver cirrhosis (child B,C)
normal individuals

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis
Time Frame: 19/4/2023 - 30/4/2024
Spontaneous bacterial peritonitis (SBP) is a serious complication of ascites that can lead to death and can be described as an acute infection of ascites without any certain source of infection SBP is considered the most common infection in cirrhotic patients with ascites. SBP is diagnosed by the presence of ≥250 polymorphonuclear leukocyte (PMNL)/mm3 in the ascetic fluid in absence of surgical and treatable causes of intra-abdominal infections SBP has many pictures of clinical presentation SBP can be asymptomatic and patients pass unnoticed or can discovered accidentally may have local symptoms and signs of peritonitis such as abdominal pain, and tachypnea or may present with signs of deteriorated liver function in form of gastrointestinal bleeding, shock and renal failure
19/4/2023 - 30/4/2024

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-23-04-11-MS

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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