Dynamic Effects of Online HDF on Cardiac Function and Myo... | NCT02494843

Studies
Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)

NCT02494843

Sponsor

University of Nottingham

Status

Completed

Last Update Posted

Apr 30, 2020Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Other Postprocedural Cardiac Functional Disturbances
Myocardial Perfusion

Interventions

online Hemodiafiltration
Hemodialysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Jul 7, 2015

First Submission Date that Met QC Criteria

Jul 7, 2015

First Posted Date

Jul 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2020

Last Update Posted Date

Apr 30, 2020Actual

Name	Class
Fresenius Medical Care Deutschland GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to characterise, in detail, the cardiac structure, function and perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to ascertain if haemodiafiltration provides relative myocardial protection compared to conventional haemodialysis.

Detailed Description

Trial Configuration: Non-blinded crossover pilot study Setting: Secondary care Sample size estimate: This is a pilot study therefore power calculations are not appropriate. A group size of 12 participants has been selected for feasibility.

Number of participants: 12 patients to complete study Description of interventions

6 sessions of conventional haemodialysis each lasting 4 hours
6 sessions of online haemodiafiltration each lasting 4 hours
2 sessions of Cardiac MRI each lasting 6 hours in total to take place around 6th session of dialysis Randomisation and blinding: This is an open study. Statistical methods: All continuous variables will be tested for normality. The primary and continuous secondary endpoints will be compared between the two modalities using a paired t test or Wilcoxon signed rank test as appropriate. The association between categorical variables will be tested using the Chi squared or Fischer's Exact test. An alpha error at 0.05 will be judged as significant.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Online haemodiafiltration	Active Comparator		Other: online Hemodiafiltration Other: Hemodialysis
Haemodialysis	Active Comparator		Other: online Hemodiafiltration Other: Hemodialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
online Hemodiafiltration	Other	Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF		2 week

Secondary Outcomes

Measure	Description	Time Frame
The change in segmental cardiac perfusion during conventional HD and HDF		2 week
The change in global and segmental cardiac function as measured by phase-contrast MRI		2 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75 years
Able to give informed consent
CKD5 on chronic haemodialysis
Receiving dialysis via an arteriovenous fistula
Must be able to follow simple instruction in English (on safety grounds for MRI scans)

Exclusion Criteria:

Change in ideal dry weight in 4 weeks prior to recruitment
Instability on dialysis in 4 weeks prior to recruitment leading to either:
- Emergency medical attention
- Infusion of additional fluid
- Loss in consciousness
- Arrhythmia
- Chest pain
Dialysed via a synthetic line or graft
Qa < 500ml/min
NYHA Stage IV heart failure
Active infection or malignancy
Contraindication to MRI scanning including claustrophobia
Mental incapacity to consent
Pregnancy or planning pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017583	Hemodiafiltration
D006435	Renal Dialysis
D003956	Dialysis

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016060	Sorption Detoxification
D006440	Hemofiltration

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Browse Branches

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