Kidney TransplantationNCT02459470
Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation
A study testing Fluid loading in people with Kidney Transplantation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim pf this prospective study is to investigate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients undergoing kidney transplantation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Fluid loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic renal failure patients undergoing renal transplantation
Who cannot join
- patients with cardiac arrhythmia
- patients with reduced left ventricular function (EF < 40%)
- patients with valvular heart disease
- patients intracardiac shunt
- patients with pulmonary hypertension
- patients with extensive peripheral vascular disease
- patients with preoperative use of vasopressors or inotropics
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Seoul Hospital, Samsung Medical Center
Seoul, 135-710
About this study
Official title: Utility of Stroke Volume Variation and Pulse Pressure Variation for Predicting Fluid Responsiveness in Chronic Renal Failure Patients Undergoing Kidney Transplantation
The aim pf this prospective study is to investigate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients undergoing kidney transplantation.
Read the detailed description
Optimal intraoperative fluid management guided by central venous pressure (CVP), a traditional intravascular volume status indicator has been established to improve transplanted graft function during renal transplantation. Recently, stroke volume variation (SVV) and pulse pressure variation (PPV), dynamic preload indices derived from the arterial waveform are increasingly advocated as predictors of fluid responsiveness in anesthetized patients and critically ill patients. However, their usefulness in renal failure patients undergoing renal transplantation has not been investigated. Thus, the aims of this study is to investigate accuracy of SVV and PPV for predicting fluid responsiveness in patients undergoing kidney transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- Fluid loading
- Keywords
- Fluid Responsiveness, Pulse Pressure Variation, Stroke Volume Variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid loadingProcedure or surgery
Also called HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland
fluid loading was performed by using 7ml/kg of 6% hydroxyethyl starch within 10 min to all patients
| Study group | Role | What they receive |
|---|---|---|
| SVV and PPV | Experimental | SVV(stroke volume variation): recorded using the Flotrac/Vigileo system (Edwards Lifesciences)
PPV(pulse pressure variation): recorded using philips Intelivue MP70 monitors (Philips Medical System)
Intervention: Other: Fluid loading using HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland Receives: Procedure: Fluid loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system
predictable of stroke volume variation from FloTrac/Vigileo system for fluid responsiveness
Measured: within 5 minutes after fluid expansion
pulse pressure variation from philips Intelivue MP70 monitor
predictable of pulse pressure variation from philips Intelivue MP70 monitor for fluid responsiveness
Measured: within 5 minutes after fluid expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaab Soo Kim, M.D, Ph.D., Principal investigator, Department of Anesthesiology and Pain medicie, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459470
- Sponsor's protocol ID
- 2013-03-080
- Other IDs
- 2013-03-180
- Status last verified
- Dec 2012
- First submitted
- 14 May 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Stroke Volume Variation and Pulse Pressure Variation for Predicting Fluid Responsiveness in Chronic Renal Failure Patients Undergoing Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02459470
- Acronym / sponsor ID
- 2013-03-080
- Conditions
- Kidney Transplantation
- Keywords
- Fluid Responsiveness, Pulse Pressure Variation, Stroke Volume Variation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim pf this prospective study is to investigate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients undergoing kidney transplantation.
Detailed description
Optimal intraoperative fluid management guided by central venous pressure (CVP), a traditional intravascular volume status indicator has been established to improve transplanted graft function during renal transplantation. Recently, stroke volume variation (SVV) and pulse pressure variation (PPV), dynamic preload indices derived from the arterial waveform are increasingly advocated as predictors of fluid responsiveness in anesthetized patients and critically ill patients. However, their usefulness in renal failure patients undergoing renal transplantation has not been investigated. Thus, the aims of this study is to investigate accuracy of SVV and PPV for predicting fluid responsiveness in patients undergoing kidney transplantation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SVV and PPV | Experimental | Procedure: Fluid loadingSVV(stroke volume variation): recorded using the Flotrac/Vigileo system (Edwards Lifesciences) PPV(pulse pressure variation): recorded using philips Intelivue MP70 monitors (Philips Medical System) Intervention: Other: Fluid loading using HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic renal failure patients undergoing renal transplantation
Key exclusion criteria (7 listed)
- patients with cardiac arrhythmia
- patients with reduced left ventricular function (EF < 40%)
- patients with valvular heart disease
- patients intracardiac shunt
- patients with pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid loadingAlso: HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerlandfluid loading was performed by using 7ml/kg of 6% hydroxyethyl starch within 10 min to all patients | Procedure or surgery | SVV and PPV |
Primary outcome
stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system
Time frame: within 5 minutes after fluid expansion
predictable of stroke volume variation from FloTrac/Vigileo system for fluid responsiveness
pulse pressure variation from philips Intelivue MP70 monitor
Time frame: within 5 minutes after fluid expansion
predictable of pulse pressure variation from philips Intelivue MP70 monitor for fluid responsiveness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Related trials for Kidney Transplantation
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaab Soo Kim, M.D, Ph.D. principal investigator
Department of Anesthesiology and Pain medicie, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid loading in people with Kidney Transplantation, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system (time frame: within 5 minutes after fluid expansion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.