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)
100
1
3
14.9
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
  • 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

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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2018