Evaluation of Nail Fold Microcirculation in CKD

Chronic Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03682952
• Other study ID #: XYFY2018-KL034-01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2018
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Alprostadil Injection
Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. French. — View Citation

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. Chinese. — View Citation

Yuksel S, Pancar Yuksel E, Yenercag M, Soylu K, Zengin H, Gulel O, Meriç 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nailfold microcirculation morphological integral	Nail fold capillary microscopy examination	Up to three and a half months
Primary	Nailfold microcirculation blood flow integral	Nail fold capillary microscopy examination	Up to three and a half months
Primary	Nail fold microcirculation perivascular loop integral	Nail fold capillary microscopy examination	Up to three and a half months
Secondary	The content of blood serum creatinine	Intravenous blood sampling	Up to three and a half months
Secondary	The content of blood urea nitrogen	Intravenous blood sampling,uronoscopy	Up to three and a half months
Secondary	The content of blood cystatin C	Intravenous blood sampling	Up to three and a half months
Secondary	eGFR	Intravenous blood sampling	Up to three and a half months
Secondary	The content of blood albumin	Intravenous blood sampling	Up to three and a half months
Secondary	The quantification of urinary protein	Uronoscopy	Up to three and a half months
Secondary	The content of hemoglobin	Intravenous blood sampling	Up to three and a half months