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Evaluation of Nail Fold Microcirculation in CKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682952
Recruitment Status : Unknown
Verified June 2018 by The Affiliated Hospital of Xuzhou Medical University.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of Xuzhou Medical University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
Drug Information available for: Alprostadil

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



Primary Outcome Measures :
  1. Nailfold microcirculation morphological integral [ Time Frame: Up to three and a half months ]
    Nail fold capillary microscopy examination

  2. Nailfold microcirculation blood flow integral [ Time Frame: Up to three and a half months ]
    Nail fold capillary microscopy examination

  3. Nail fold microcirculation perivascular loop integral [ Time Frame: Up to three and a half months ]
    Nail fold capillary microscopy examination


Secondary Outcome Measures :
  1. The content of blood serum creatinine [ Time Frame: Up to three and a half months ]
    Intravenous blood sampling

  2. The content of blood urea nitrogen [ Time Frame: Up to three and a half months ]
    Intravenous blood sampling,uronoscopy

  3. The content of blood cystatin C [ Time Frame: Up to three and a half months ]
    Intravenous blood sampling

  4. eGFR [ Time Frame: Up to three and a half months ]
    Intravenous blood sampling

  5. The content of blood albumin [ Time Frame: Up to three and a half months ]
    Intravenous blood sampling

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

  7. The content of hemoglobin [ Time Frame: Up to three and a half months ]
    Intravenous blood sampling



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682952


Locations
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China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Sponsors and Collaborators
The Affiliated Hospital of Xuzhou Medical University
Investigators
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Study Director: Dong Sun, MD Affiliated Hospital of Xuzhou Medical University
Publications:
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Responsible Party: The Affiliated Hospital of Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03682952    
Other Study ID Numbers: XYFY2018-KL034-01
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Alprostadil
Beraprost
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents