Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations

NCT06367205 | Recruiting

• 1 other identifier: LY2023-135-A
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 3

Brief Summary

Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.

Conditions

Delayed Graft Function; End Stage Renal Disease; Kidney Transplantation

Keywords

Norepinephrine; Goal-directed fluid therapy; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The incidence of delayed graft function (DGF)

  The need for dialytic intervention within the initial week post-transplantation

  Patients will be followed from postoperative day 1 to 7.

Secondary Outcomes (7)

• The area under the curve of serum creatinine levels from postoperative day 1 to 7

  Patients will be followed from postoperative day 1 to 7.

• Duration of DGF

  Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.

• Number of dialysis sessions during postoperative hospitalization

  Patients will be followed from surgery completion to discharge，an average of 20 days.

• Total urine output on the second postoperative day

  Patients will be followed on the second postoperative day.

• Duration of intensive care unit (ICU) stay

  Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.

Other Outcomes (4)

• The incidence of acute rejection during hospitalization

  Patients will be followed from surgery completion to discharge, an average of 20 days.

• The survival rates of transplanted kidneys at the one-year postoperative mark

  Patients will be followed from surgery completion to one year after surgery.

• The survival rates of transplanted patients at the one-year postoperative mark

  Patients will be followed from surgery completion to one year after surgery.

Study Arms (2)

Goal-Directed Fluid Therapy (GDFT) group

EXPERIMENTAL

Following anesthesia induction, patients will be connected to the FlowTrac/Vigileo monitoring system to facilitate the recording of pertinent hemodynamic parameters, including stroke volume variation (SVV), stroke volume, and cardiac output. Then, Norepinephrine Infusion Combined with Goal-directed Fluid Therapy will be administered. Efforts are made to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg.

Drug: Goal-Directed Fluid Therapy (GDFT)

Regular Fluid Therapy group

ACTIVE COMPARATOR

Patients will not undergo monitoring with the FlowTrac/Vigileo system throughout the whole procedure. Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg until the conclusion of the surgical procedure.

Drug: Regular Fluid Therapy

Interventions

Goal-Directed Fluid Therapy (GDFT) DRUG

Norepinephrine will be administered intravenously at a rate of 0.06 µg/kg/min, followed by the implementation of fluid therapy guided by SVV until reaching our target. In instances where SVV ≤ 13%, indicative of adequate effective circulating blood volume, the fluid infusion rate will be adjusted to 1 ml/kg/h. Conversely, if SVV \> 13%, denoting inadequate effective circulating blood volume, a rapid infusion of 1 ml/kg of crystalloid fluid will be administered over 2 minutes, with subsequent observation of fluid reactivity after a further 2-minute interval. This process is reiterated until SVV ≤ 13% is attained. Should SVV \> 13% recurs during surgery, the aforementioned intervention is repeated.

Also known as: GDFT

Goal-Directed Fluid Therapy (GDFT) group

Regular Fluid Therapy DRUG

Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary

Regular Fluid Therapy group

Eligibility Criteria

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

You may qualify if:

• Recipients aged 18 years or older
• Scheduled to undergo kidney transplantations under general anesthesia
• Cadaveric kidney transplantations
• Sign the informed consent form

You may not qualify if:

• Donors aged under 18 years
• Donor kidneys classified as Maastricht category I or II
• Contraindications to radial artery catheterization
• Pregnancy
• Cardiac dysfunction (exercise tolerance less than 4 METS)
• Severe liver dysfunction (Child Pugh C-grade)
• Respiratory diseases with tidal volume intolerance exceeding 8ml/kg
• Severe arrhythmias, including atrial fibrillation, frequent atrial or ventricular premature beats, moderate or severe aortic and mitral regurgitation
• Double-kidney transplantations
• Simultaneous organ or additional surgeries during kidney transplantations
• Repeat kidney transplantations
• Concurrent participation in other clinical trials
• Patients deemed ineligible by researchers

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (3)

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

General Hospital of Northern Theatre Command

Shenyang, Liaoning, 110016, China

NOT YET RECRUITING

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Delayed Graft Function; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Diansan Su, Dr.

  Department of Anesthesiology Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su, Dr.

CONTACT

+862168383702; diansansu@yahoo.com

Muyan Shi, B.S.

CONTACT

+862168383702; jsqdsmy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: March 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (3)