Evaluation of Nail Fold Microcirculation in CKD

NCT03682952 | Unknown Phase 4 DMC

• 1 other identifier: XYFY2018-KL034-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Renal Disease

Keywords

Chronic Renal Disease; Nail fold microcirculation; Interventional therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• The content of blood serum creatinine

  Up to three and a half months

• The content of blood urea nitrogen

  Up to three and a half months

• The content of blood cystatin C

  Up to three and a half months

• eGFR

  Up to three and a half months

• The content of blood albumin

  Up to three and a half months

Study Arms (3)

Experimental group

EXPERIMENTAL

Alprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients.

Drug: Alprostadil Injection; Drug: Beraprost sodium tablets

Anemia control group

NO INTERVENTION

Anemia patients

Control group

NO INTERVENTION

Healthy person

Interventions

Alprostadil Injection DRUG

Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks.

Experimental group

Beraprost sodium tablets DRUG

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.

Experimental group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Related Publications (7)

• 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.

  PMID: 2314527 BACKGROUND

• 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.

  PMID: 24955181 BACKGROUND

• 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.

  PMID: 24951141 BACKGROUND

• 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.

  PMID: 3096534 BACKGROUND

• 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.

  PMID: 24607833 BACKGROUND

• 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.

  PMID: 8863336 BACKGROUND

• 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.

  PMID: 11279575 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Alprostadil; beraprost

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Dong Sun, MD

  The Affiliated Hospital of Xuzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 25, 2018
• Study Start: February 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)