Clinical trial NCT03682952: Evaluation of Nail Fold Microcirculation in CKD
Official title: Evaluation of Nail Fold Microcirculation and Interventional Therapy in Patients With Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Renal Disease
Keywords: Chronic Renal Disease
Nail fold microcirculation
Interventional therapy
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nailfold microcirculation morphological integral
timeFrame: Up to three and a half months
measure: Nailfold microcirculation blood flow integral
timeFrame: Up to three and a half months
measure: Nail fold microcirculation perivascular loop integral
timeFrame: Up to three and a half months
Secondary outcomes:
measure: The content of blood serum creatinine
timeFrame: Up to three and a half months
measure: The content of blood urea nitrogen
timeFrame: Up to three and a half months
measure: The content of blood cystatin C
timeFrame: Up to three and a half months
measure: eGFR
timeFrame: Up to three and a half months
measure: The content of blood albumin
timeFrame: Up to three and a half months
measure: The quantification of urinary protein
timeFrame: Up to three and a half months
measure: The content of hemoglobin
timeFrame: Up to three and a half months
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Dong Sun, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1159/000185838.
citation: 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.
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. French.
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. No abstract available. Chinese.
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.
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.
citation: 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.