Kidney Transplant; ComplicationsNCT03949036
Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation
A study testing Crystalloid fluid administration with the target of stroke volume variation ≤ 12% and Crystalloid fluid administration with the target of stroke volume variation ≤ 6% in people with Kidney Transplant; Complications and Renal Failure Chronic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Renal Failure Chronic
- What is being tested?
- Crystalloid fluid administration with the target of stroke volume variation ≤ 12% and Crystalloid fluid administration with the target of stroke volume variation ≤ 6%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2019to 25 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients who are undergoing living donor kidney transplantation with continuous radial artery pressure monitoring
Who cannot join
- Patients who have cardiac arrhythmia of atrial fibrillation, multiple ventricular premature complex
- Cardiac systolic dysfunction with left ventricle ejection fraction <50%
- Continuous arterial pressure monitoring at the site other than radial artery.
- Patients who are considered to be intolerant to rapid fluid administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation: A Randomized Controlled Trial
The investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.
Read the detailed description
The adequate preload target of fluid management has not yet been established during kidney transplantation. Traditionally, sufficient intravascular volume status has been recommended to maintain perfusion to renal graft. Stroke volume variation was reported to be superior to the traditional target of central venous pressure. In this regard, the investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.
- Being tested
- Crystalloid fluid administration with the target of stroke volume variation ≤ 12%, Crystalloid fluid administration with the target of stroke volume variation ≤ 6%
- Keywords
- kidney transplantation, preload index, stroke volume variation, goad-directed therapy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalloid fluid administration with the target of stroke volume variation ≤ 12%Other
The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 12%
Crystalloid fluid administration with the target of stroke volume variation ≤ 6%Other
The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 6%
| Study group | Role | What they receive |
|---|---|---|
| target of Stroke Volume Variation ≤ 6% | Experimental | The rate of intraoperative fluid administration will be adjusted to achieve the target of Stroke Volume Variation ≤ 6%. A crystalloid bolus of 200 ml will be repeatedly administered every 20 min until the target was achieved. The basal rate of fluid administration will be 3 ml/kg/hr. Receives: Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 6% |
| target of Stroke Volume Variation ≤ 12% | Active comparator | The rate of intraoperative fluid administration will be adjusted to achieve the target of Stroke Volume Variation ≤ 12%. A crystalloid bolus of 200 ml will be repeatedly administered every 20 min until the target was achieved. The basal rate of fluid administration will be 3 ml/kg/hr. Receives: Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 12% |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum neutrophil-gelatinase-associated lipocalin (NGAL)
urine biomarker of renal injury
Measured: at the end of surgery
Secondary outcomes (16)
serum neutrophil-gelatinase-associated lipocalin (NGAL)
urine biomarker of renal injury
Measured: at the anesthesia induction procedure
Delayed graft function determined by the incidence of hemodialysis
Delayed graft function determined by the incidence of hemodialysis
Measured: during the first postoperative week
Delayed graft function determined by urine output (less than 1200 ml)
Delayed graft function determined by urine output (less than 1200 ml)
Measured: during the first postoperative day
Delayed graft function determined by serum creatinine
Delayed graft function determined by serum creatinine (No decrease in creatinine of more than 10% of preoperative value)
Measured: during the 48 hours after surgery
Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)
Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)
Measured: during the 10 days after surgery
Delayed graft function determined by glomerular filtration rate
Delayed graft function determined by glomerular filtration rate (less than 10 ml/min/m2)
Measured: during the 24 hours after surgery
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
Measured: during the first postoperative week
Immediate graft function
serum creatinine decrease less than 70% of preoperative value
Measured: after eight days after surgery
slow graft function
serum creatinine decrease greater than 70% of preoperative value
Measured: after eight days after surgery
serum creatinine value
serum creatinine value
Measured: first postoperative day
serum creatinine value
serum creatinine value
Measured: third postoperative day
serum creatinine value
serum creatinine value
Measured: seventh postoperative day
Incidence of pneumonia
Incidence of pneumonia
Measured: during the first postoperative week
Incidence of wound infection
Incidence of wound infection
Measured: during the first postoperative week
Incidence of postoperative bleeding
Incidence of postoperative bleeding
Measured: during the first postoperative week
hospital length of stay
hospital length of stay
Measured: the first postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 May 2019
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial of two parallel groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949036
- Sponsor's protocol ID
- 1811-028-983
- Status last verified
- Oct 2021
- First submitted
- 11 May 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03949036
- Acronym / sponsor ID
- 1811-028-983
- Keywords
- kidney transplantation, preload index, stroke volume variation, goad-directed therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 14 May 2019 (actual)
- 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 investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.
Detailed description
The adequate preload target of fluid management has not yet been established during kidney transplantation. Traditionally, sufficient intravascular volume status has been recommended to maintain perfusion to renal graft. Stroke volume variation was reported to be superior to the traditional target of central venous pressure. In this regard, the investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial of two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| target of Stroke Volume Variation ≤ 6% | Experimental | Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 6%The rate of intraoperative fluid administration will be adjusted to achieve the target of Stroke Volume Variation ≤ 6%. A crystalloid bolus of 200 ml will be repeatedly administered every 20 min until the target was achieved. The basal rate of fluid administration will be 3 ml/kg/hr. |
| target of Stroke Volume Variation ≤ 12% | Active comparator | Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 12%The rate of intraoperative fluid administration will be adjusted to achieve the target of Stroke Volume Variation ≤ 12%. A crystalloid bolus of 200 ml will be repeatedly administered every 20 min until the target was achieved. The basal rate of fluid administration will be 3 ml/kg/hr. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients who are undergoing living donor kidney transplantation with continuous radial artery pressure monitoring
Key exclusion criteria (4 listed)
- Patients who have cardiac arrhythmia of atrial fibrillation, multiple ventricular premature complex
- Cardiac systolic dysfunction with left ventricle ejection fraction <50%
- Continuous arterial pressure monitoring at the site other than radial artery.
- Patients who are considered to be intolerant to rapid fluid administration
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 |
|---|---|---|
| Crystalloid fluid administration with the target of stroke volume variation ≤ 12%The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 12% | Other | target of Stroke Volume Variation ≤ 12% |
| Crystalloid fluid administration with the target of stroke volume variation ≤ 6%The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 6% | Other | target of Stroke Volume Variation ≤ 6% |
Primary outcome
serum neutrophil-gelatinase-associated lipocalin (NGAL)
Time frame: at the end of surgery
urine biomarker of renal injury
16 secondary outcomes
serum neutrophil-gelatinase-associated lipocalin (NGAL)
Time frame: at the anesthesia induction procedure
Delayed graft function determined by the incidence of hemodialysis
Time frame: during the first postoperative week
Delayed graft function determined by urine output (less than 1200 ml)
Time frame: during the first postoperative day
Delayed graft function determined by serum creatinine
Time frame: during the 48 hours after surgery
Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)
Time frame: during the 10 days after surgery
Delayed graft function determined by glomerular filtration rate
Time frame: during the 24 hours after surgery
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
Time frame: during the first postoperative week
Immediate graft function
Time frame: after eight days after surgery
slow graft function
Time frame: after eight days after surgery
serum creatinine value
Time frame: first postoperative day
serum creatinine value
Time frame: third postoperative day
serum creatinine value
Time frame: seventh postoperative day
Incidence of pneumonia
Time frame: during the first postoperative week
Incidence of wound infection
Time frame: during the first postoperative week
Incidence of postoperative bleeding
Time frame: during the first postoperative week
hospital length of stay
Time frame: the first postoperative month
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 21 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant; Complications
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystalloid fluid administration with the target of stroke volume variation ≤ 12% and Crystalloid fluid administration with the target of stroke volume variation ≤ 6% in people with Kidney Transplant; Complications and Renal Failure Chronic, run by Seoul National University Hospital 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 4 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 21 Oct 2021. 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?
serum neutrophil-gelatinase-associated lipocalin (NGAL) (time frame: at the end of surgery). 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 21 Oct 2021.