Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454428
Status:
COMPLETED
Last Update Posted:
2007-03-30
First Post:
2007-03-29
Brief Title:
Randomized Trial of Pulsatile vs Non Pulsatile Perfusion on Short Term Changes in Kidney Function Using an Intra-Aortic Ballooon Pump During Cardioplegic Arrest in Patients Undergoing Myocardial Reperfusion
Sponsor:
University of Catanzaro
Organization:
University of Catanzaro
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Linear flow during cardiopulmonary bypass CPB frequently induces renal damage
We will evaluate whether automatic intra-aortic balloon pump IABP induce pulsatile perfusion preserves renal function in patients undergoing myocardial revascularization at different risk for renal damage
100 patients undergoing preoperative IABP will be stratified for renal function
Intervention The patients will be randomized to non-pulsatile CPB during cardioplegic arrest or automatic IABP induced pulsatile CPB
Renal function daily diuretics complication rate lactatemia and other biochemical indices will be compared in patients
We will prospectively enrolle 100 patients undergoing isolated primary high-risk coronary artery bypass grafting for severe left main stem disease 70 narrowing or left-main equivalent three-vessels coronary disease On admission to our institution the patients will be stratified for renal function according to KDOQI and randomly assigned to Group A or Group B We will exclude from the study patients older than 75 years andor with kidney disease Stage 4 GFR 15 - 29 mlmin173 m2 andor with other splanchnic organ comorbidities liver or mesenteric impairment abdominal aortic aneurysm abdominal arteries vasculopathy andor severe autoimmune disease
The patients randomized to Group A n50 will receive a preoperative IABP treatment before induction of anesthesia with IABP turned off during cardioplegic arrest and restarted with a 11 IABP mode immediately after cross-clamp removal as is the traditionally adopted perioperative IABP support the other 50 Group B will receive standard preoperative treatment with IABP which will switche into an automatic 80 bpm mode during cross-clamp time and switche again into a 11 IABP after cross-clamp removal in order to achieve a pulsatile perfusion during the entire intra-operative time-course
The patients will be stratified in 2 subgroups according to the preoperative renal function a subgroup will include 64 patients 32 allocated in Group A and 32 in Group B with stage 1 or 2 Stage 1 GFR 90 mlmin173 m2 - Stage 2 GFR 60 - 89 mlmin173 m2 and therefore considered at lower-risk for post-CPB renal damage the remaining 36 18 for each group with KDOQI Stage 3 of kidney disease GFR 30 - 59 mlmin173 m2 will be considered at higher-risk for perioperative renal complications 19
We will evaluate whether automatic intra-aortic balloon pump IABP induce pulsatile perfusion preserves renal function in patients undergoing myocardial revascularization at different risk for renal damage
100 patients undergoing preoperative IABP will be stratified for renal function
Intervention The patients will be randomized to non-pulsatile CPB during cardioplegic arrest or automatic IABP induced pulsatile CPB
Renal function daily diuretics complication rate lactatemia and other biochemical indices will be compared in patients
We will prospectively enrolle 100 patients undergoing isolated primary high-risk coronary artery bypass grafting for severe left main stem disease 70 narrowing or left-main equivalent three-vessels coronary disease On admission to our institution the patients will be stratified for renal function according to KDOQI and randomly assigned to Group A or Group B We will exclude from the study patients older than 75 years andor with kidney disease Stage 4 GFR 15 - 29 mlmin173 m2 andor with other splanchnic organ comorbidities liver or mesenteric impairment abdominal aortic aneurysm abdominal arteries vasculopathy andor severe autoimmune disease
The patients randomized to Group A n50 will receive a preoperative IABP treatment before induction of anesthesia with IABP turned off during cardioplegic arrest and restarted with a 11 IABP mode immediately after cross-clamp removal as is the traditionally adopted perioperative IABP support the other 50 Group B will receive standard preoperative treatment with IABP which will switche into an automatic 80 bpm mode during cross-clamp time and switche again into a 11 IABP after cross-clamp removal in order to achieve a pulsatile perfusion during the entire intra-operative time-course
The patients will be stratified in 2 subgroups according to the preoperative renal function a subgroup will include 64 patients 32 allocated in Group A and 32 in Group B with stage 1 or 2 Stage 1 GFR 90 mlmin173 m2 - Stage 2 GFR 60 - 89 mlmin173 m2 and therefore considered at lower-risk for post-CPB renal damage the remaining 36 18 for each group with KDOQI Stage 3 of kidney disease GFR 30 - 59 mlmin173 m2 will be considered at higher-risk for perioperative renal complications 19
Detailed Description:
Linear flow during cardiopulmonary bypass CPB frequently induces renal damage
We will evaluate whether automatic intra-aortic balloon pump IABP induced pulsatile perfusion preserves renal function in patients undergoing myocardial revascularization at different risk for renal damage
100 patients undergoing preoperative IABP will be stratified for renal function
Intervention The patients will be randomized to non-pulsatile CPB during cardioplegic arrest or automatic IABP induced pulsatile CPB
Renal function daily diuretics complication rate lactatemia and other biochemical indices will be compared in patients
We will prospectively enrolle 100 patients undergoing isolated primary high-risk coronary artery bypass grafting for severe left main stem disease 70 narrowing or left-main equivalent three-vessels coronary disease On admission to our institution the patients will be stratified for renal function according to KDOQI and randomly assigned to Group A or Group B We will exclude from the study patients older than 75 years andor with kidney disease Stage 4 GFR 15 - 29 mlmin173 m2 andor with other splanchnic organ comorbidities liver or mesenteric impairment abdominal aortic aneurysm abdominal arteries vasculopathy andor severe autoimmune disease
The patients randomized to Group A n50 will receive a preoperative IABP treatment before induction of anesthesia with IABP turned off during cardioplegic arrest and restarted with a 11 IABP mode immediately after cross-clamp removal as is the traditionally adopted perioperative IABP support the other 50 Group B will receive standard preoperative treatment with IABP which will switche into an automatic 80 bpm mode during cross-clamp time and switche again into a 11 IABP after cross-clamp removal in order to achieve a pulsatile perfusion during the entire intra-operative time-course
The patients will be stratified in 2 subgroups according to the preoperative renal function a subgroup will include 64 patients 32 allocated in Group A and 32 in Group B with stage 1 or 2 Stage 1 GFR 90 mlmin173 m2 - Stage 2 GFR 60 - 89 mlmin173 m2 and therefore considere at lower-risk for post-CPB renal damage the remaining 36 18 for each group with KDOQI Stage 3 of kidney disease GFR 30 - 59 mlmin173 m2 will be considered at higher-risk for perioperative renal complications 19
The study protocol has been approved by the institutions Ethical CommitteeInstitutional Review Board and informed consent will be obtained from each patient
Anesthesia Anesthetic technique will be standardized induction will consiste of iv propofol infusion 3 mgkg combined with fentanyl 010 mgKg Neuromuscular blockade will be achieved by 4 mgh pancuronium bromide and lungs will be ventilated to normocapnia with air and oxygen 45-50 Propofol infusion 150-200 μgKg per min and isoflurane 05 inspired concentration will maintaine anesthesia Inotropes will be started immediately after aortic cross-clamp removal to maintain adequate mean systemic pressure always starting with enoximone at a dosage of 5 μgKgmin The need for further increase in inotropes will be record inotropes will be defined as low-dose when enoximone will be administered at a dosage 5 μgKgmin medium-dose when enoximone will be between 6 and 10 μgKgmin or dobutamine will add at a dosage between 5 and 10 μgKgmin and high-dose when enoximone or dobutamine will be 10 μgKgmin or epinephrine add at any dose
Surgical technique and cardiopulmonary bypass According to our Institutional policy we will insert IABP 75 or 8 Fr 34 or 40 ml according to the body surface area balloon Datascope Corp Fairfield NJ connected to a Datascope pump Datascope Corp Fairfield NJ percutaneously with the sheetless technique through the best femoral artery before induction of anesthesia in order to better support the perioperative hemodynamic of patients undergoing surgery for severe left main stem or 3-vessels left-main equivalent disease The correct placement of IABP will be always assessed by postoperative chest X-ray or transesophageal echocardiography Patients will receive anticoagulation with enoxaparin with a target activated partial thromboplastin time 40 seconds starting when the postoperative bleeding was controlled usually within 6 hours IABP will be withdrawn when hemodynamic stability will restore ie a cardiac index 20 Lm2 per minute with only minimal pharmacologic inotropic support dobutamine or enoximone at 5 µgkg per minute CPB and surgical techniques will be standardized and not changed during the study period Heparin will be given at a dose of 300 IUkg to achieve a target activated clotting time of 480 seconds or above Blood recovery with an autotransfusion device Autotrans Dideco Mirandola Modena Italy will be performed intraoperatively in all cases A level of hemoglobin lower than 8 gdl will be used as an indication for blood transfusion Standard CPB circuit will be used The extracorporeal circuit will be primed with 1000 ml of Ringers Lactate solution and 40 mg of heparin Systemic temperature will be kept between 32 and 34 C Myocardial protection will be achieved with intermittent antegrade and retrograde hyperkalemic blood cardioplegia Total CPB flow will be maintained at 26 Lmin-1m-2 In Group A patients IABP will be turned off during cardioplegic arrest maintaining a standard non-pulsatile CPB Group B patients will undergo IABP-induced pulsatile CPB during cardioplegic arrest with pulsatile flow maintained by an automatic 80 bpm mode until aortic declamping
Endpoints The primary endpoint of this study is the evaluation of the renal function as assessed by measuring GFR in the perioperative period In all patients will be evaluated perioperative renal function in-hospital mortality and morbidity and complications in-hospital and intensive therapy unit ITU stay IABP-related complications Renal function is primarily evaluated by GFR calculated using the abbreviated Modification of Diet in Renal Disease MDRD study equation recommended by KDOQI as the preferred equation for the calculation of GFR in adults taking into account serum creatinine age race gender 22 and secondarily by other indices such as urine output need for diuretics blood urea nitrogen BUN Plasma lactate concentrations will be measured to indirectly assess the adequacy of tissue perfusion 20 Acute renal insufficiency ARI is defined as a decrease greater than 50 over preoperative value of calculated GFR Acute renal failure ARF is defined as any postoperative renal insufficiency requiring first-time hemofiltration dialysis or any other renal replacement therapy RRT In-hospital mortality is defined as any death occurring during hospital stay or in the first 30 postoperative days Hospital morbidity is defined as any complication requiring specific therapy or causing a delay in hospital or ITU discharge IABP-related complications is defined as any aortic dissection or perforation limb or mesenteric ischemia or infection or hemorrhage at the balloon entry point
Biochemical analysis All patients will undergo pre- and perioperatively routine laboratory investigations including standard hemogram serum levels of creatinine urea nitrogen calcium phosphate glucose albumin electrolytes albumin transaminases -glutamyl-transpeptidase lactic acid dehydrogenase bilirubin acid-base parameters troponin I and lactic acid The determinations of the majority of these parameters will be conducted preoperatively before anesthetic induction and at 12 24 48 and 72 hours postoperatively In order to evaluate the adequacy of myocardial protection techniques Troponin I will be measured on coronary sinus blood samples obtained from the retrograde cardioplegic cannula 10 minutes following completion of proximal anastomoses The Troponin I assays will be carried out using diagnostic kits provided by Beckman Coulter Fullerton California AccuTnITM Access Immunoassay System
Statistical analysis Statistical analysis will be performed by the SPSS program for Windows version 101 SPSS Inc Chicago IL Continuous variables will be presented as mean standard deviation and categorical variables as absolute numbers andor percentages Data will be checked for normality before statistical analysis Normally-distributed continuous variables will be compared using the unpaired t test whereas the Mann-Whitney U test will be used for those variables that are not normally distributed Categorical variables will be analyzed using either the chi-square test or Fischers exact test Comparison between and within groups will be made using two-way analysis of variance for repeated measures Comparisons will be considered significant if p005
We will evaluate whether automatic intra-aortic balloon pump IABP induced pulsatile perfusion preserves renal function in patients undergoing myocardial revascularization at different risk for renal damage
100 patients undergoing preoperative IABP will be stratified for renal function
Intervention The patients will be randomized to non-pulsatile CPB during cardioplegic arrest or automatic IABP induced pulsatile CPB
Renal function daily diuretics complication rate lactatemia and other biochemical indices will be compared in patients
We will prospectively enrolle 100 patients undergoing isolated primary high-risk coronary artery bypass grafting for severe left main stem disease 70 narrowing or left-main equivalent three-vessels coronary disease On admission to our institution the patients will be stratified for renal function according to KDOQI and randomly assigned to Group A or Group B We will exclude from the study patients older than 75 years andor with kidney disease Stage 4 GFR 15 - 29 mlmin173 m2 andor with other splanchnic organ comorbidities liver or mesenteric impairment abdominal aortic aneurysm abdominal arteries vasculopathy andor severe autoimmune disease
The patients randomized to Group A n50 will receive a preoperative IABP treatment before induction of anesthesia with IABP turned off during cardioplegic arrest and restarted with a 11 IABP mode immediately after cross-clamp removal as is the traditionally adopted perioperative IABP support the other 50 Group B will receive standard preoperative treatment with IABP which will switche into an automatic 80 bpm mode during cross-clamp time and switche again into a 11 IABP after cross-clamp removal in order to achieve a pulsatile perfusion during the entire intra-operative time-course
The patients will be stratified in 2 subgroups according to the preoperative renal function a subgroup will include 64 patients 32 allocated in Group A and 32 in Group B with stage 1 or 2 Stage 1 GFR 90 mlmin173 m2 - Stage 2 GFR 60 - 89 mlmin173 m2 and therefore considere at lower-risk for post-CPB renal damage the remaining 36 18 for each group with KDOQI Stage 3 of kidney disease GFR 30 - 59 mlmin173 m2 will be considered at higher-risk for perioperative renal complications 19
The study protocol has been approved by the institutions Ethical CommitteeInstitutional Review Board and informed consent will be obtained from each patient
Anesthesia Anesthetic technique will be standardized induction will consiste of iv propofol infusion 3 mgkg combined with fentanyl 010 mgKg Neuromuscular blockade will be achieved by 4 mgh pancuronium bromide and lungs will be ventilated to normocapnia with air and oxygen 45-50 Propofol infusion 150-200 μgKg per min and isoflurane 05 inspired concentration will maintaine anesthesia Inotropes will be started immediately after aortic cross-clamp removal to maintain adequate mean systemic pressure always starting with enoximone at a dosage of 5 μgKgmin The need for further increase in inotropes will be record inotropes will be defined as low-dose when enoximone will be administered at a dosage 5 μgKgmin medium-dose when enoximone will be between 6 and 10 μgKgmin or dobutamine will add at a dosage between 5 and 10 μgKgmin and high-dose when enoximone or dobutamine will be 10 μgKgmin or epinephrine add at any dose
Surgical technique and cardiopulmonary bypass According to our Institutional policy we will insert IABP 75 or 8 Fr 34 or 40 ml according to the body surface area balloon Datascope Corp Fairfield NJ connected to a Datascope pump Datascope Corp Fairfield NJ percutaneously with the sheetless technique through the best femoral artery before induction of anesthesia in order to better support the perioperative hemodynamic of patients undergoing surgery for severe left main stem or 3-vessels left-main equivalent disease The correct placement of IABP will be always assessed by postoperative chest X-ray or transesophageal echocardiography Patients will receive anticoagulation with enoxaparin with a target activated partial thromboplastin time 40 seconds starting when the postoperative bleeding was controlled usually within 6 hours IABP will be withdrawn when hemodynamic stability will restore ie a cardiac index 20 Lm2 per minute with only minimal pharmacologic inotropic support dobutamine or enoximone at 5 µgkg per minute CPB and surgical techniques will be standardized and not changed during the study period Heparin will be given at a dose of 300 IUkg to achieve a target activated clotting time of 480 seconds or above Blood recovery with an autotransfusion device Autotrans Dideco Mirandola Modena Italy will be performed intraoperatively in all cases A level of hemoglobin lower than 8 gdl will be used as an indication for blood transfusion Standard CPB circuit will be used The extracorporeal circuit will be primed with 1000 ml of Ringers Lactate solution and 40 mg of heparin Systemic temperature will be kept between 32 and 34 C Myocardial protection will be achieved with intermittent antegrade and retrograde hyperkalemic blood cardioplegia Total CPB flow will be maintained at 26 Lmin-1m-2 In Group A patients IABP will be turned off during cardioplegic arrest maintaining a standard non-pulsatile CPB Group B patients will undergo IABP-induced pulsatile CPB during cardioplegic arrest with pulsatile flow maintained by an automatic 80 bpm mode until aortic declamping
Endpoints The primary endpoint of this study is the evaluation of the renal function as assessed by measuring GFR in the perioperative period In all patients will be evaluated perioperative renal function in-hospital mortality and morbidity and complications in-hospital and intensive therapy unit ITU stay IABP-related complications Renal function is primarily evaluated by GFR calculated using the abbreviated Modification of Diet in Renal Disease MDRD study equation recommended by KDOQI as the preferred equation for the calculation of GFR in adults taking into account serum creatinine age race gender 22 and secondarily by other indices such as urine output need for diuretics blood urea nitrogen BUN Plasma lactate concentrations will be measured to indirectly assess the adequacy of tissue perfusion 20 Acute renal insufficiency ARI is defined as a decrease greater than 50 over preoperative value of calculated GFR Acute renal failure ARF is defined as any postoperative renal insufficiency requiring first-time hemofiltration dialysis or any other renal replacement therapy RRT In-hospital mortality is defined as any death occurring during hospital stay or in the first 30 postoperative days Hospital morbidity is defined as any complication requiring specific therapy or causing a delay in hospital or ITU discharge IABP-related complications is defined as any aortic dissection or perforation limb or mesenteric ischemia or infection or hemorrhage at the balloon entry point
Biochemical analysis All patients will undergo pre- and perioperatively routine laboratory investigations including standard hemogram serum levels of creatinine urea nitrogen calcium phosphate glucose albumin electrolytes albumin transaminases -glutamyl-transpeptidase lactic acid dehydrogenase bilirubin acid-base parameters troponin I and lactic acid The determinations of the majority of these parameters will be conducted preoperatively before anesthetic induction and at 12 24 48 and 72 hours postoperatively In order to evaluate the adequacy of myocardial protection techniques Troponin I will be measured on coronary sinus blood samples obtained from the retrograde cardioplegic cannula 10 minutes following completion of proximal anastomoses The Troponin I assays will be carried out using diagnostic kits provided by Beckman Coulter Fullerton California AccuTnITM Access Immunoassay System
Statistical analysis Statistical analysis will be performed by the SPSS program for Windows version 101 SPSS Inc Chicago IL Continuous variables will be presented as mean standard deviation and categorical variables as absolute numbers andor percentages Data will be checked for normality before statistical analysis Normally-distributed continuous variables will be compared using the unpaired t test whereas the Mann-Whitney U test will be used for those variables that are not normally distributed Categorical variables will be analyzed using either the chi-square test or Fischers exact test Comparison between and within groups will be made using two-way analysis of variance for repeated measures Comparisons will be considered significant if p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None