RBR-48x3xv Comparative study of the influence of blood flow, oxygenation and hemodynamics generated during the use of…

Date of registration: 09/25/2011 ^(mm/dd/yyyy)
Last approval date : 09/25/2011 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1120-6508

• Public title:

  en

  Comparative study of the influence of blood flow, oxygenation and hemodynamics generated during the use of extracorporeal circulation machine

  pt-br

  Estudo comparativo entre a influência de fluxo sanguíneo, oxigenação e hemodinâmica gerados durante a utilização da máquina de circulação extracorpórea

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 0247/10.07.09
    Issuing authority: Ministério da Saúde - Secretaria de Assistência a Saúde Instituto Nacional de Cardiologia

Sponsors

• Primary sponsor: Instituto Nacional de Cardiologia
• Secondary sponsor:
  • Institution: Maria aparecida Nogueira de Lima Marcondes Salgado
• Supporting source:
  • Institution: Instituto Nacional de Cardiologia

Health conditions

• Health conditions:

  en

  heart failure, coronary insufficiency, myocardial infarction

  pt-br

  insuficiência cardíaca, insuficiência coronariana, infarto do miocárdio

• General descriptors for health conditions:

  en

  C14 Cardiovascular diseases

  pt-br

  C14 Doenças cardiovasculares

  es

  C14 Enfermedades cardiovasculares

  en

  C23 Pathological conditions, signs and symptoms

  pt-br

  C23 Condições patológicas, sinais e sintomas

  es

  C23 Condiciones patológicas, signos y síntomas

• Specific descriptors:

Interventions

• Interventions:

  en

  Intervention increased flow generated by the pump to bypass L/min/m2 3.0 to 3.5 during cardiopulmonary bypass in myocardial revascularization Control flow generated by the extracorporeal pump 2.2 to 2.7 L/min/m2 during cardiopulmonary bypass in CABG

  pt-br

  Intervenção aumento do fluxo gerado pela bomba de extracorpórea para 3,0 a 3,5 L/min/m2, durante a circulação extracorpórea em revascularização do miocardio Controle fluxo gerado pela bomba de extracorporea de 2,2 a 2,7L/min/m2 durante a circulação extracorpórea em revascularização do miocardio

• Descriptors:

  en

  E04.292 Extracorporeal Circulation

  pt-br

  E04.292 Circulação Extracorpórea

  es

  E04.292 Circulación Extracorporea

  en

  H02.403.810.803 Thoracic Surgery

  pt-br

  H02.403.810.803 Cirurgia Torácica

  es

  H02.403.810.803 Cirugía Torácica

Recruitment

• Study status: data analysis completed
• Countries
  • Brazil
• Date first enrollment: 08/01/2010 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  73	-	18 Y	75 Y

• Inclusion criteria:

  en

  Patient admitted to the National Institute of Cardiology, which have coronary heart disease and were referred for surgery for isolated primary CABG, patients with ejection fraction greater than or equal to 45%, both sexes; aged between 18 and 75 years, during cardiopulmonary bypass use of vacuum-assisted venous drainage and use of normothermia during cardiopulmonary bypass

  pt-br

  Paciente internados no Instituto Nacional de Cardiologia, que apresentam insuficiência coronariana e foram indicados para cirurgia de revascularização do miocárdio primária isolada; pacientes com fração de ejeção maior ou igual a 45%; ambos os sexos; idade compreendida entre 18 e 75 anos; uso durante a circulação extracorpórea de drenagem venosa assistida a vácuo e uso de normotermia durante a circulação extracorpórea

• Exclusion criteria:

  en

  Patient admitted to the National Institute of Cardiology, which appear as disease and / or diagnosis associated with surgery, recent myocardial infarction (less than 3 months), recent stroke (less than 3 months, unstable angina, urgent or emergency surgery, diabetes mellitus decompensated - disease of diabetic ketoacidosis, renal failure - creatinine clearance <30 ml / min

  pt-br

  Paciente internados no Instituto Nacional de Cardiologia que apresentam como patologia e/ou diagnóstico cirurgias associadas; infarto do miocárdio recente (menos de 3 meses); acidente vascular encefálico recente (menos de 3 meses; angina instável; cirurgia de emergência ou urgência; diabetes mellitus descompensada - doença de cetoacidose diabética; insuficiência renal - depuração de creatinina < 30 ml/min

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	treatment	parallel	2	double-blind	randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Decline in value of lactate during cardiopulmonary bypass in at least 30%. Normal value of lactate less than 3 mmol / L

  pt-br

  Diminuição do valor dos lactatos durante a circulação extracorpórea em pelo menos 30%. Valor normal de lactato menor que 3 mmoL/L

• Secondary outcomes:

  en

  The oxy-hemodynamic variables, oxygen delivery (350 to 450 mL/min/m2), oxygen consumption (90 mL/min/m2), mixed venous oxygen saturation (70 to 80%), venous blood carbon dioxide gradient carbon (less than 10 mmHg) and arteriovenous difference of pH (less than 0.1), must be within these values ??so that tissue perfusion is adequate.

  pt-br

  As variáveis oxi-hemodinâmicas, oferta de oxigênio (de 350 a 450 mL/min/m2), consumo de oxigênio (90 mL/min/m2), saturação venosa mista de oxigênio ( 70 a 80%), gradiente veno arterial de dióxido de carbono ( menor que 10 mmHg)e diferença arteriovenoso de pH( menor que 0,1); devem estar compreendidas dentre esses valores para que a perfusão tecidual seja adequada.

Contacts

• Public contact
  • Full name: Maria Aparecida Marcondes Salgado
  • • Address: Rua das Laranjeiras,374
    • City: Rio de Janeiro / Brazil
    • Zip code: 22240-006
  • Phone: 21-22853344
  • Email: mamsalgado@gmail.com
  • Affiliation: Instituto Nacional de Cardiologia
   
• Scientific contact
  • Full name: Maria Aparecida Salgado
  • • Address: Rua das Laranjeiras, 374
    • City: Rio de Janeiro / Brazil
    • Zip code: 22240006
  • Phone: (55) (21) 2285-3344
  • Email: mamsalgado@gmail.com
  • Affiliation: Instituto Nacional de Cardiologia
  • Full name: Maria Aparecida Marcondes Salgado
  • • Address: Rua das Laranjeiras,374
    • City: Rio de Janeiro / Brazil
    • Zip code: 22240-006
  • Phone: 21-22853344
  • Email: mamsalgado@gmail.com
  • Affiliation: Instituto Nacional de Cardiologia
   
• Site contact
  • Full name: Maria Aparecida Marcondes Salgado
  • • Address: Rua das Laranjeiras, 374
    • City: Rio de Janeiro / Brazil
    • Zip code: 22240006
  • Phone: 21-22853344
  • Email: gpecic@gmail.com
  • Affiliation: Instituto Nacional de Cardiologia
   

Additional links:

• Download in ICTRP format