Association of MLR With Risk of Death and Cardiovascular Events in PD Patients

NCT04238338 | Unknown

• 1 other identifier: Jun Zhang
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

The current incidence of chronic kidney disease (CKD) in China is approximately 10.8%, with approximately 119 million patients. Among them, patients with end-stage renal disease (ESRD) are about 200-250 cases per million population. At present, the main renal replacement therapy is: hemodialysis (HD) or peritoneal dialysis (PD). Compared with HD, PD is easy to operate, better preserves residual renal function, has early survival advantages, and is more cost-effective. Despite this, the prognosis of PD patients is still not ideal, and cardiovascular disease (CVD) remains the leading cause of death in PD patients. Persistent inflammatory states are critical in the pathogenesis of CVD such as atherosclerosis and vascular calcification, and lead to protein energy expenditure and premature death outcomes in patients with CKD. Therefore, screening for markers that predict the risk of CVD in dialysis patients is essential. Some novel inflammatory markers have been shown to have diagnostic and prognostic value in ESRD patients in terms of inflammation, malnutrition, cardiovascular calcification, all-cause, and risk of CVD death. Among them, blood cell related parameters such as neutrophil / lymphocyte ratio (NLR) and monocyte / lymphocyte ratio (MLR)can reflect both inflammation and immune deficiency. NLR, MLR has been proposed as a new inflammatory biomarker and a potential predictor of cardiovascular risk. Studies have reported that MLR is associated with cardiovascular death and all-cause death risk in hemodialysis patients, and is superior to NLR. However, the relationship between MLR and the prognosis of patients with peritoneal dialysis is rarely reported. Therefore, in this study, we aimed to evaluate the association of MLR with risk of death and cardiovascular events in PD patients.

Conditions

Peritoneal Dialysis; Inflammation

Keywords

monocyte / lymphocyte ratio; peritoneal dialysis; cardiovascular disease; Inflammation; death

Outcome Measures

Primary Outcomes (1)

• All-cause mortality and cardiovascular mortality

  Proportion of all-cause and cardiovascular deaths during follow-up

  12 months

Secondary Outcomes (2)

• The Incidence of cardiovascular events

  12 months

• The Incidence of peritoneal dialysis-associated peritonitis

  12 months

Study Arms (2)

high MLR group

Divided into high MLR group and low MLR group according to the median of monocyte / lymphocyte ratio(MLR). Patients undergo peritoneal dialysis 3, 4 or 5 times per day, with a daily peritoneal dialysate dose of approximately 6000-10000 ml. The glucose concentration of peritoneal dialysate varies depending on the specific requirements of the individual patient for ultrafiltration volume. Three concentrations of glucose peritoneal dialysis solution are available for peritoneal dialysis patients. The low concentration is 1.5% or 2.5% and the high concentration is 4.25%. In principle, a 1.5% glucose peritoneal dialysis solution is first applied, or a high concentration of 4.25% glucose peritoneal dialysis solution can be appropriately applied according to the actual situation. Other drugs continued to be used in patients with other diseases.

Other: monocyte / lymphocyte ratio

low MLR group

Divided into high MLR group and low MLR group according to the median of monocyte / lymphocyte ratio(MLR). Patients undergo peritoneal dialysis 3, 4 or 5 times per day, with a daily peritoneal dialysate dose of approximately 6000-10000 ml. The glucose concentration of peritoneal dialysate varies depending on the specific requirements of the individual patient for ultrafiltration volume. Three concentrations of glucose peritoneal dialysis solution are available for peritoneal dialysis patients. The low concentration is 1.5% or 2.5% and the high concentration is 4.25%. In principle, a 1.5% glucose peritoneal dialysis solution is first applied, or a high concentration of 4.25% glucose peritoneal dialysis solution can be appropriately applied according to the actual situation. Other drugs continued to be used in patients with other diseases.

Other: monocyte / lymphocyte ratio

Interventions

monocyte / lymphocyte ratio OTHER

The lymphocyte / monocyte ratio should be tested every 3-6months after the start of the study, and the final value is the average

high MLR group; low MLR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent continuous ambulatory peritoneal dialysis in the Department of Nephrology of Southern Medical University Zhujiang Hospital，and voluntarily signed informed consent to join the study.

You may qualify if:

• Patients who underwent continuous ambulatory peritoneal dialysis for at least 3 months.

You may not qualify if:

• Age \<18 years, with acute or chronic infections such as lung infection,peritoneal dialysis-related peritonitis, urinary system infection, etc .
• With history of malignant tumor or blood disease.
• With rheumatic immune diseases, such as systemic lupus erythematosus, vasculitis , Sjögren's syndrome, etc .
• Used immunosuppressants, such as glucocorticoids, calcineurin inhibitors, etc .
• Women during pregnancy.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

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MeSH Terms

Conditions

Inflammation; Cardiovascular Diseases; Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Zhang, Doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhang, Doctor

CONTACT

13538786006; gzh_zj@qq.com

Xun Tang, Doctor

CONTACT

13538792873; 1847672118@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 23, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)