Evaluation of Nail Fold Microcirculation in CKD

Phase 4

• Conditions: Chronic Renal Disease
• Interventions: Drug: Alprostadil Injection; Drug: Beraprost sodium tablets

• Registration Number: NCT03682952
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

Brief Summary

To evaluation of nailfold microcirculation in patients with chronic renal failure and its intervention therapy

Detailed Description

The aim of this study is to study the changes of Nailfold Microcirculation in patients with chronic renal failure, to clarify the correlation between the changes of Nailfold Microcirculation and renal function, and to explore whether nailfold microcirculation can be used as an indicator of renal microcirculation in patients with chronic renal failure, and to provide a noninvasive method for the clinical evaluation of renal microcirculation in patients with chronic renal failure.

Study Timeline

• Study Start: 2018-02-01
• Status Verified: 2018-06
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-26
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• CKD patients
• Without dialysis
• Blood pressure ≤ 140/90mmHg

Exclusion Criteria

• Polycystic kidney
• Endocrine system disease
• Cardio-cerebrovascular disease
• Rheumatic immune disease
• Peripheral vascular disease
• Hematological diseases
• Respiratory disease
• Infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Alprostadil Injection	Alprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients.
Experimental group	Beraprost sodium tablets	Alprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients.

Primary Outcome Measures

Name	Time	Method
Nailfold microcirculation morphological integral	Up to three and a half months	Nail fold capillary microscopy examination
Nailfold microcirculation blood flow integral	Up to three and a half months	Nail fold capillary microscopy examination
Nail fold microcirculation perivascular loop integral	Up to three and a half months	Nail fold capillary microscopy examination

Secondary Outcome Measures

Name	Time	Method
The content of blood urea nitrogen	Up to three and a half months	Intravenous blood sampling，uronoscopy
The content of blood cystatin C	Up to three and a half months	Intravenous blood sampling
eGFR	Up to three and a half months	Intravenous blood sampling
The content of blood serum creatinine	Up to three and a half months	Intravenous blood sampling
The content of blood albumin	Up to three and a half months	Intravenous blood sampling
The quantification of urinary protein	Up to three and a half months	Uronoscopy
The content of hemoglobin	Up to three and a half months	Intravenous blood sampling

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China