Comparison of balanced solutions in abdominal oncological surgery: a pragmatic, randomized, controlled, double-blind study between Plasmafundin and Ringer's Lactate

Assessment of the impact of two perioperative volume replacement solutions in oncological abdominal surgery on the occurrence of metabolic acidosis: comparison between Plasmafunfin and Ringer Lactate

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-4h25ytk

Enrollment

Unknown

Registered

2024-06-14

Start date

2020-06-01

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

Postoperative Complications

Interventions

This is a two-arm, double-blind, randomized controlled clinical study. A total of 134 people meeting the eligibility criteria will be probabilistically allocated to one or another intervention group u

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Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Major elective oncological abdominal surgeries, expected to last more than 4 hours and requiring a post-operative ICU; age 18 or over; understanding and signing the consent form by the patient or guardian; both genders

Exclusion criteria

Exclusion criteria: Urgent or emergency surgery; severe sepsis or septic shock; patients under 18 years of age; chronic obstructive pulmonary disease; decompensated diabetes mellitus; Body Mass Index (BMI) above 35 kg/m2; left ventricular ejection fraction less than 35%; chronic renal failure on dialysis; participation in another interventional study that has an influence on the intervention of this study

Design outcomes

Primary

Measure	Time frame
Expected outcome: It is expected to find a relative difference between the groups in the lactate value after 4 hours of surgery in the Plasmafundin (acetate and gluconate as buffers) group of 1.4+-0.6 (CI 1.18; 1.62) versus in the Ringer Lactate group (lactate as buffer) of 2.8+-1.4 (IC 2.28; 3.32), verified through serial analysis of arterial blood gases, based on the finding of a variation of at least 5% in the measurements betwen groups ;Outcome found: A difference was observed between the values between the groups in the lactate value after 4 hours of surgery, having been lower in the Plasmafundin group (acetate and gluconate as buffers) of (median (Q1; Q3)) 8.00( 6.00; 10.00) (mg/dL) versus in the Ringer Lactate group (lactate as buffer) of (median (Q1; Q3)) 11.00(9.00; 14.00) (mg/dL), verified through serial analysis of arterial blood gases, based on the finding of a p value <0.001	—

Measure

Time frame

Expected outcome: It is expected to find a relative difference between the groups in the lactate value after 4 hours of surgery in the Plasmafundin (acetate and gluconate as buffers) group of 1.4+-0.6 (CI 1.18; 1.62) versus in the Ringer Lactate group (lactate as buffer) of 2.8+-1.4 (IC 2.28; 3.32), verified through serial analysis of arterial blood gases, based on the finding of a variation of at least 5% in the measurements betwen groups ;Outcome found: A difference was observed between the values between the groups in the lactate value after 4 hours of surgery, having been lower in the Plasmafundin group (acetate and gluconate as buffers) of (median (Q1; Q3)) 8.00( 6.00; 10.00) (mg/dL) versus in the Ringer Lactate group (lactate as buffer) of (median (Q1; Q3)) 11.00(9.00; 14.00) (mg/dL), verified through serial analysis of arterial blood gases, based on the finding of a p value <0.001

—

Secondary

Measure	Time frame
No secondary outcomes were expected.	—

Countries

Brazil

Contacts

Public ContactGabriel Valente

ICESP - Instituto do Câncer do Estado de São Paulo

gvalente93@gmail.com+55-11-38933615

Outcome results

None listed

Source: REBEC (via WHO ICTRP)