Evaluation of Nail Fold Microcirculation in CKD

• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03682952
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Disease	Drug: Alprostadil Injection; Drug: Beraprost sodium tablets	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of Nail Fold Microcirculation and Interventional Therapy in Patients With Chronic Renal Failure
• Actual Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Apr 30, 2019
• Anticipated Study Completion Date: Apr 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Nailfold microcirculation morphological integral [Up to three and a half months]

   Nail fold capillary microscopy examination

2. Nailfold microcirculation blood flow integral [Up to three and a half months]

   Nail fold capillary microscopy examination

3. Nail fold microcirculation perivascular loop integral [Up to three and a half months]

   Nail fold capillary microscopy examination

Secondary Outcome Measures

1. The content of blood serum creatinine [Up to three and a half months]

   Intravenous blood sampling

2. The content of blood urea nitrogen [Up to three and a half months]

   Intravenous blood sampling，uronoscopy

3. The content of blood cystatin C [Up to three and a half months]

   Intravenous blood sampling

4. eGFR [Up to three and a half months]

   Intravenous blood sampling

5. The content of blood albumin [Up to three and a half months]

   Intravenous blood sampling

6. The quantification of urinary protein [Up to three and a half months]

   Uronoscopy

7. The content of hemoglobin [Up to three and a half months]

   Intravenous blood sampling

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China	221000

Sponsors and Collaborators

• The Affiliated Hospital of Xuzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Paparde A, Nēringa-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.
• 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.
• 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.
• 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.

• Responsible Party: The Affiliated Hospital of Xuzhou Medical University
• ClinicalTrials.gov Identifier: NCT03682952
• Other Study ID Numbers: XYFY2018-KL034-01
• First Posted: Sep 25, 2018
• Last Update Posted: Sep 26, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Affiliated Hospital of Xuzhou Medical University: Chronic Renal Disease; Nail fold microcirculation; Interventional therapy
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Alprostadil; Beraprost

Study Results

No Results Posted as of Sep 26, 2018