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

NCT03949036 | Completed DMC

• 1 other identifier: 1811-028-983
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant; Complications; Renal Failure Chronic

Keywords

kidney transplantation; preload index; stroke volume variation; goad-directed therapy

Outcome Measures

Primary Outcomes (1)

• serum neutrophil-gelatinase-associated lipocalin (NGAL)

  urine biomarker of renal injury

  at the end of surgery

Secondary Outcomes (16)

• serum neutrophil-gelatinase-associated lipocalin (NGAL)

  at the anesthesia induction procedure

• Delayed graft function determined by the incidence of hemodialysis

  during the first postoperative week

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

  during the first postoperative day

• Delayed graft function determined by serum creatinine

  during the 48 hours after surgery

• Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)

  during the 10 days after surgery

Study Arms (2)

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.

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.

Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 12%

Interventions

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%

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%

target of Stroke Volume Variation ≤ 6%

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients do not know which group they will be enrolled. The outcome assessor will be blind to the group assignment of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized controlled trial of two parallel groups.

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 14, 2019
• Study Start: May 1, 2019
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)