Evaluation of Nail Fold Microcirculation in CKD

Evaluation of Nail Fold Microcirculation and Interventional Therapy in Patients With Chronic Renal Failure

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

Study Overview

• Status: Unknown
• Conditions: Chronic Renal Disease
• Intervention / Treatment: Drug: Alprostadil Injection; Drug: Beraprost sodium tablets

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital Of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Alprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients.	Drug: Alprostadil Injection; Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks.; Drug: Beraprost sodium tablets; Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks ,then they take beraprost sodium tablets 40ug orally three times perday for 3 months.
No Intervention: Anemia control group; Anemia patients
No Intervention: Control group; Healthy person

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nailfold microcirculation morphological integral	Nail fold capillary microscopy examination	Up to three and a half months
Nailfold microcirculation blood flow integral	Nail fold capillary microscopy examination	Up to three and a half months
Nail fold microcirculation perivascular loop integral	Nail fold capillary microscopy examination	Up to three and a half months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Investigators: Study Director: Dong Sun, MD, The Affiliated Hospital Of Xuzhou Medical University

Publications and helpful links

General Publications

• Leunissen KM, van den Berg BW, Cheriex EC, Slaaf DW, Reneman RS, van Hooff JP. Influence of fluid removal during haemodialysis on macro- and skin microcirculation. Haemodynamic pathophysiologic study of fluid removal during haemodialysis. Nephron. 1990;54(2):162-8. doi: 10.1159/000185838.
• Yuksel S, Pancar Yuksel E, Yenercag M, Soylu K, Zengin H, Gulel O, Meric M, Aydin F, Senturk N, Sahin M. Abnormal nail fold capillaroscopic findings in patients with coronary slow flow phenomenon. Int J Clin Exp Med. 2014 Apr 15;7(4):1052-8. eCollection 2014.
• Senet P, Fichel F, Baudot N, Gaitz JP, Tribout L, Frances C. [Nail-fold capillaroscopy in dermatology]. Ann Dermatol Venereol. 2014 Jun-Jul;141(6-7):429-37. doi: 10.1016/j.annder.2014.04.120. Epub 2014 Jun 2. French.
• Yuan SY. [Nail-fold microcirculatory flow in liver cirrhosis: diabetes mellitus and systemic lupus erythematosus]. Zhonghua Yi Xue Za Zhi. 1986 Aug;66(8):473-5, 512. No abstract available. Chinese.
• Paparde A, Neringa-Martinsone K, Plakane L, Aivars JI. Nail fold capillary diameter changes in acute systemic hypoxia. Microvasc Res. 2014 May;93:30-3. doi: 10.1016/j.mvr.2014.02.013. Epub 2014 Mar 6.
• Schumann L, Korten G, Holdt B, Holtz M. Microcirculation of the fingernail fold in CAPD patients: preliminary observations. Perit Dial Int. 1996 Jul-Aug;16(4):412-6.
• Hasegawa K, Pereira BP, Pho RW. The microvasculature of the nail bed, nail matrix, and nail fold of a normal human fingertip. J Hand Surg Am. 2001 Mar;26(2):283-90. doi: 10.1053/jhsu.2001.21519.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Renal Disease; Nail fold microcirculation; Interventional therapy
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Beraprost; Alprostadil
• Other Study ID Numbers: XYFY2018-KL034-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No