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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949036
• Other study ID #: 1811-028-983
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 25, 2020

Study information

• Verified date: October 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Kidney Transplant; Complications
• Renal Failure Chronic

Intervention

Other:
• 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%
• 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%

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum neutrophil-gelatinase-associated lipocalin (NGAL)	urine biomarker of renal injury	at the end of surgery
Secondary	serum neutrophil-gelatinase-associated lipocalin (NGAL)	urine biomarker of renal injury	at the anesthesia induction procedure
Secondary	Delayed graft function determined by the incidence of hemodialysis	Delayed graft function determined by the incidence of hemodialysis	during the first postoperative week
Secondary	Delayed graft function determined by urine output (less than 1200 ml)	Delayed graft function determined by urine output (less than 1200 ml)	during the first postoperative day
Secondary	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)	during the 48 hours after surgery
Secondary	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)	during the 10 days after surgery
Secondary	Delayed graft function determined by glomerular filtration rate	Delayed graft function determined by glomerular filtration rate (less than 10 ml/min/m2)	during the 24 hours after surgery
Secondary	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)	during the first postoperative week
Secondary	Immediate graft function	serum creatinine decrease less than 70% of preoperative value	after eight days after surgery
Secondary	slow graft function	serum creatinine decrease greater than 70% of preoperative value	after eight days after surgery
Secondary	serum creatinine value	serum creatinine value	first postoperative day
Secondary	serum creatinine value	serum creatinine value	third postoperative day
Secondary	serum creatinine value	serum creatinine value	seventh postoperative day
Secondary	Incidence of pneumonia	Incidence of pneumonia	during the first postoperative week
Secondary	Incidence of wound infection	Incidence of wound infection	during the first postoperative week
Secondary	Incidence of postoperative bleeding	Incidence of postoperative bleeding	during the first postoperative week
Secondary	hospital length of stay	hospital length of stay	the first postoperative month