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Effects of Different Fluids Administered During the Renal Transplantation from Deceased Donor in the Renal Function after the Transplant

Effects of Plasma-Lyte or Normal Saline on Renal Function After Renal Transplantation from a Deceased Donor. A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-9t7r5p
Enrollment
Unknown
Registered
2017-06-12
Start date
2017-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney failure, kidney transplantation

Interventions

Experimental groups: (1) 52 patients undergoing deceased-donor renal transplantation who will be given intraoperatively a balanced fluid solution with sodium, chloride, potassium and magnesium, pH equ
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Sponsors

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
Lead Sponsor
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with chronic renal disease under hemodialysis, aged 18 to 65 years, both genders, physical status III and IV according to the American Society of Anesthesiologist (ASA)

Exclusion criteria

Exclusion criteria: Patients with preoperative hemoglobin less than 8 g/dL and those under peritoneal dialysis

Design outcomes

Primary

MeasureTime frame
Incidence of delayed graft function (yes or no), verified by the need to perform hemodialysis up to 7 days after the transplantation. It is expected a 50% reduction (60% to 30%) in the incidence of delayed graft function with the administration of the balanced solution with pH equal to 7,4 (Plasma-Lyte), as compared to the 0,9% sodium chloride solution administration.

Secondary

MeasureTime frame
Acid-base balance modifications: pH, sodium bicarbonate and base excess values at the end of the transplant will be mesured. Values of sodium, potassium, chloride, calcium and magnesium at the end of the transplant will be mesured. Mean values of these variables will be compared by variance analysis. P < 0.05 will be considered significative.

Countries

Brazil

Contacts

Public ContactPaulo do Nascimento Junior

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP

pnasc@fmb.unesp.br+55(14)38801414

Outcome results

None listed

Source: REBEC (via WHO ICTRP)