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NaCl 0,9% vs. Latate's Ringer> Effects on postoperative results of myocardical revascularization surgery with cardiopulmonary by pass

NaCl 0,9% vs. Latate's Ringer> effects on postoperative results of Myocardical Revascularization Surgery with cardiopulmonary by pass

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-6xvdmz
Enrollment
Unknown
Registered
2018-05-08
Start date
2017-05-28
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

Acute renal failure

Interventions

Control Group: 152 patients who will undergoing revascularization myocardical surgery used for volume replacement during the surgery and for the preparation of the prime and cardioplegia solutions of
Drug

Sponsors

Fundação Universitária de Cardiologia
Lead Sponsor
Fundação Universitária de Cardiologia
Collaborator

Eligibility

Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients submitted to surgical myocardial revascularization with CPB, elective and primary, with age ranging between 50 and 75 years old and both sexes

Exclusion criteria

Exclusion criteria: Preoperative: Urgency or emergency surgery, INR higher 1,3, when are lower than 100.000, altered KTTP in the absence of heparine use, use of antiplatelet agents except acetylsalicylic acid, renal insufficiency and or creatinine higher 2, hepatic insufficiency and or GOT e GPT levels more than two times the normal value, previous coagulopathy, pregnancy, breast-feeding, serum potassium higher 5.5 during preoperative period. Diagnosed diseases Von Willebrand, hemophilia, sepsis, hepatic cirrhosis and seizures Transoperative CPB duration higher than 160 minutes and realization of profound hypothermia with circulatory arrest

Design outcomes

Primary

MeasureTime frame
renal failure in the postoperative period, through the measurements of creatinine and urinary output within 48 hours after the surgical procedure, the criteria of the Acute Kidney Injure Network (AKIN), which proposes classification in three stages Stage 1: Increased serum creatinine by more than 0.3 mg / dl or 150-200% of baseline, or urine output less than 0.5 ml / kg / min for more than 6 hours Stage 2: Increased serum creatinine by 200 to 300% of baseline, or urine output less than 0.5 ml / kg / min for more than 12 hours Stage 3: Increased creatinine by more than 300% of the baseline, or urine output less than 0.3 ml / kg / min for 24 hours, or anuria for 12 hours

Secondary

MeasureTime frame
Comparison of the time of time of hospitalization in the postoperative unit of time of mechanical ventilation ;Observation of adverse reactions of the solutions, such as metabolic acidosis and hyperlactatemia, observed through alteration of laboratory values by pH, HCO3 bicarbonate, BE base excess, potassium, sodium, lactate, hemoglobin and hematocrit measurements, according to values during and after the surgical procedure until the patient leaves the postoperative unit;Observation of differences in postoperative bleeding in the 48-hour period, reoperations and mortality during hospital stay

Countries

Brazil

Contacts

Public ContactJéssica Thais de Oliveira

Fundação Universitária de Cardiologia

j.thais_@hotmail.com+55-051-98110401

Outcome results

None listed

Source: REBEC (via WHO ICTRP)