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Evaluation of Nail Fold Microcirculation in CKD

Primary Purpose

Chronic Renal Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Alprostadil Injection
Beraprost sodium tablets
Sponsored by
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Disease focused on measuring Chronic Renal Disease, Nail fold microcirculation, Interventional therapy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Experimental group

Anemia control group

Control group

Arm Description

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

Anemia patients

Healthy person

Outcomes

Primary Outcome Measures

Nailfold microcirculation morphological integral
Nail fold capillary microscopy examination
Nailfold microcirculation blood flow integral
Nail fold capillary microscopy examination
Nail fold microcirculation perivascular loop integral
Nail fold capillary microscopy examination

Secondary Outcome Measures

The content of blood serum creatinine
Intravenous blood sampling
The content of blood urea nitrogen
Intravenous blood sampling，uronoscopy
The content of blood cystatin C
Intravenous blood sampling
eGFR
Intravenous blood sampling
The content of blood albumin
Intravenous blood sampling
The quantification of urinary protein
Uronoscopy
The content of hemoglobin
Intravenous blood sampling

Full Information

First Posted
September 12, 2018
Last Updated
September 25, 2018
Sponsor
The Affiliated Hospital of Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03682952
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Disease
Keywords
Chronic Renal Disease, Nail fold microcirculation, Interventional therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Alprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients.
Arm Title
Anemia control group
Arm Type
No Intervention
Arm Description
Anemia patients
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Healthy person
Intervention Type
Drug
Intervention Name(s)
Alprostadil Injection
Intervention Description
Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Beraprost sodium tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nailfold microcirculation morphological integral
Description
Nail fold capillary microscopy examination
Time Frame
Up to three and a half months
Title
Nailfold microcirculation blood flow integral
Description
Nail fold capillary microscopy examination
Time Frame
Up to three and a half months
Title
Nail fold microcirculation perivascular loop integral
Description
Nail fold capillary microscopy examination
Time Frame
Up to three and a half months
Secondary Outcome Measure Information:
Title
The content of blood serum creatinine
Description
Intravenous blood sampling
Time Frame
Up to three and a half months
Title
The content of blood urea nitrogen
Description
Intravenous blood sampling，uronoscopy
Time Frame
Up to three and a half months
Title
The content of blood cystatin C
Description
Intravenous blood sampling
Time Frame
Up to three and a half months
Title
eGFR
Description
Intravenous blood sampling
Time Frame
Up to three and a half months
Title
The content of blood albumin
Description
Intravenous blood sampling
Time Frame
Up to three and a half months
Title
The quantification of urinary protein
Description
Uronoscopy
Time Frame
Up to three and a half months
Title
The content of hemoglobin
Description
Intravenous blood sampling
Time Frame
Up to three and a half months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Sun, MD
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2314527
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.
Results Reference
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PubMed Identifier
24955181
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.
Results Reference
background
PubMed Identifier
24951141
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.
Results Reference
background
PubMed Identifier
3096534
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.
Results Reference
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PubMed Identifier
24607833
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.
Results Reference
background
PubMed Identifier
8863336
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.
Results Reference
background
PubMed Identifier
11279575
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.
Results Reference
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Evaluation of Nail Fold Microcirculation in CKD

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