Evaluation of Nail Fold Microcirculation in CKD

NCT ID: NCT03682952

Last Updated: 2018-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

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

Group Type EXPERIMENTAL

Alprostadil Injection

Intervention Type DRUG

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

Beraprost sodium tablets

Intervention Type 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.

Anemia control group

Anemia patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group

Healthy person

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alprostadil Injection

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dong Sun, MD

Role: STUDY_DIRECTOR

The Affiliated Hospital of Xuzhou Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 2314527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24955181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24951141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3096534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24607833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8863336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11279575 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XYFY2018-KL034-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.