Skip to main content
OpenTrials
Completed

NCT Number: NCT03949036

Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Transplant; Complications Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Chronic Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients who are undergoing living donor kidney transplantation with continuous radial artery pressure monitoring

Exclusion criteria

  • 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

Treatment and study plan

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%

Primary outcomes

  1. serum neutrophil-gelatinase-associated lipocalin (NGAL)

    Time frame: at the end of surgery

    urine biomarker of renal injury

Secondary outcomes

  1. serum neutrophil-gelatinase-associated lipocalin (NGAL)

    Time frame: at the anesthesia induction procedure

    urine biomarker of renal injury

  2. Delayed graft function determined by the incidence of hemodialysis

    Time frame: during the first postoperative week

    Delayed graft function determined by the incidence of hemodialysis

  3. Delayed graft function determined by urine output (less than 1200 ml)

    Time frame: during the first postoperative day

    Delayed graft function determined by urine output (less than 1200 ml)

  4. Delayed graft function determined by serum creatinine

    Time frame: during the 48 hours after surgery

    Delayed graft function determined by serum creatinine (No decrease in creatinine of more than 10% of preoperative value)

  5. 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 serum creatinine (more than 2.5 mg/dL)

  6. Delayed graft function determined by glomerular filtration rate

    Time frame: during the 24 hours after surgery

    Delayed graft function determined by glomerular filtration rate (less than 10 ml/min/m2)

  7. Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)

    Time frame: during the first postoperative week

    Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)

  8. Immediate graft function

    Time frame: after eight days after surgery

    serum creatinine decrease less than 70% of preoperative value

  9. slow graft function

    Time frame: after eight days after surgery

    serum creatinine decrease greater than 70% of preoperative value

  10. serum creatinine value

    Time frame: first postoperative day

    serum creatinine value

  11. serum creatinine value

    Time frame: third postoperative day

    serum creatinine value

  12. serum creatinine value

    Time frame: seventh postoperative day

    serum creatinine value

  13. Incidence of pneumonia

    Time frame: during the first postoperative week

    Incidence of pneumonia

  14. Incidence of wound infection

    Time frame: during the first postoperative week

    Incidence of wound infection

  15. Incidence of postoperative bleeding

    Time frame: during the first postoperative week

    Incidence of postoperative bleeding

  16. hospital length of stay

    Time frame: the first postoperative month

    hospital length of stay

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 14, 2019
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.