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Acute Post-cardiac Surgery Renal Failure: Prevention Through Individualized Intensive Hemodynamic Management (PrevHemAKI)
BACKGROUND: The incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery can reach 35% and between 2 and 5% require kidney replacement therapy during the AKI episode. The development of AKI n this context is independently associated with higher long-term mortality (5-10 years). In addition, there is strong evidence that an episode of AKI in the hospital increases the risk of developing chronic kidney disease in the medium-long term. On the other hand, once AKI has been recovered according to creatinine values, there are no established biomarkers to predict patients at risk of progression to chronic kidney disease, which will allow us to increase nephroprotection and surveillance measures in this group of patients.
STUDY DESIGN: Open-label randomized unicentric prospective study of patients undergoing valvular replacement heart surgery ± coronary bypass with acute kidney injury (AKI) risk >30% according to the Leicester Cardiosurgery scale. Patients will be randomized 1:1 in two groups: standard hemodynamic management or intensive hemodynamic management based on premorbid mean perfusion pressure (MPP). The interventional period will span from intra-operation until the first 24 hours postoperative. The incidence of AKI will be evaluated according to KDIGO criteria between 48 hours and 7 days after surgery. Patients will be followed for one year. Biomarkers of mitochondrial damage will be analyzed at various points during the follow-up to patients presenting AKI.
INTERVENTIONS:
A) Group 1/Intensive management: Intra-surgical values of ± 25% basal MAP will be maintained and once in the ICU an algorithm corresponding to group 1 based on cardiac index and ± 25% MPP will be followed for 24 hours.
B) Group 2/Standard management: MAP during surgery will be maintained > 60 mmHg according to usual protocol. Once in ICU, during the first 24 hours an algorithm corresponding to group 2 based on cardiac index, MAP and CVP will be followed.
Biomarkers of mitochondrial damage will be determined in urine in patients in both groups only in patients developing AKI according to KDIGO guidelines between 48h and 7 days.
EXPECTED RESULTS:A 50% reduction in the incidence of AKI in the intervention group compared to the control group is expected. At the same time, markers of mitochondrial damage are expected to be validated in our cohort as biomarkers of AKI progression and to investigate its usefulness as biomarkers of transition to Chronic kidney disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Kidney Injury | Behavioral: Intensive management | Not Applicable |
BACKGROUND:
The incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery can reach 35% and between 2 and 5% require kidney replacement therapy during the AKI episode. The development of AKI n this context is independently associated with higher long-term mortality (5-10 years). In addition, there is strong evidence that an episode of AKI in the hospital increases the risk of developing chronic kidney disease in the medium-long term. That is why the prevention of AKI is essential to reduce the morbidity that these patients suffer in the hospital and out-of-hospital environment. On the other hand, once AKI has been recovered according to creatinine values, there are no established biomarkers to predict patients at risk of progression to chronic kidney disease, which will allow us to increase nephroprotection and surveillance measures in this group of patients.
STUDY DESIGN:
Open-label randomized unicentric prospective study of patients undergoing valvular replacement heart surgery ± coronary bypass with acute kidney injury (AKI) risk >30% according to the Leicester Cardiosurgery scale. Patients will be randomized 1:1 in two groups: standard hemodynamic management or intensive hemodynamic management based on premorbid mean perfusion pressure (MPP). The interventional period will span from intra-operation until the first 24 hours postoperative. The incidence of AKI will be evaluated according to KDIGO criteria between 48 hours and 7 days after surgery. Patients will be followed for one year. Biomarkers of mitochondrial damage will be analyzed at various points during the follow-up to patients presenting AKI. Intention to treat population will be defined as patients who sign informed consent and undergo planned surgery.
INTERVENTIONS-ANALYSIS:
A) Group 1/Intensive management: Baseline mean blood pressure (MAP) and central venous pressure (CVP) will be measured to calculate baseline mean perfusion pressure (MPP). Intra-surgical values of ± 25% basal MAP will be maintained and once in the ICU an algorithm corresponding to group 1 based on cardiac index and ± 25% MPP will be followed for 24 hours.
B) Group 2/Standard management: MAP during surgery will be maintained > 60 mmHg according to usual protocol. Once in ICU, during the first 24 hours an algorithm corresponding to group 2 based on cardiac index, MAP and CVP will be followed. Biomarkers of mitochondrial damage will be determined in urine in patients in both groups only in patients developing AKI according to KDIGO guidelines between 48h and 7 days. The following variables will be assessed in both groups: accumulated fluid balance in first 24 hours, ICU /hospitalization length of stay, days with vasoactive support, MAKE (Major Adverse Kidney Events: mortality, need for renal replacement therapy, persistent renal dysfunction) at 30, 90 and 365 days and other AKI episodes at one year. In the patients who develop AKI, urinary markers of mitochondrial injury will also be measured at 30 days.
EXPECTED RESULTS:
A 50% reduction in the incidence of AKI in the intervention group compared to the control group is expected. At the same time, markers of mitochondrial damage are expected to be validated in our cohort as biomarkers of AKI progression and to investigate its usefulness as biomarkers of transition to Chronic kidney disease.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Acute Post-cardiac Surgery Renal Failure: Prevention Through Individualized Intensive Hemodynamic Management and Evaluation of Prognostic Biomarkers |
| Actual Study Start Date : | October 14, 2019 |
| Estimated Primary Completion Date : | December 1, 2021 |
| Estimated Study Completion Date : | December 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Intensive management
Baseline mean blood pressure (MAP) and central venous pressure (CVP) will be measured to calculate baseline mean perfusion pressure. Intra-surgical values of ± 25% basal MAP will be maintained and once in the ICU an algorithm corresponding to group 1 based on cardiac index and MPP will be followed for 24 hours. |
Behavioral: Intensive management
Management based on premorbid MAP and MPP
|
|
No Intervention: Standard management
MAP during surgery will be maintained > 60 mmHg according to usual protocol. Once in ICU, during the first 24 hours an algorithm corresponding to group 2 based on cardiac index, MAP and CVP will be followed.
|
- AKI incidence [ Time Frame: 18 months ]Reduction in the incidence of AKI
- Major kidney adverse events (MAKE) at 30, 90, 365 days [ Time Frame: 12 months ]To evaluate the incidence of MAKE in both groups
- ICU and hospital length of stay [ Time Frame: 18 months ]Days of ICU and Hospital stay
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing elective or urgent heart surgery with extracorporeal circulation at the Hospital Clínic de Barcelona.
- Valve and/or aortocoronary bypass surgery
- Risk of AKI >30% according to the Leicester Cardiosurgery scale
Exclusion Criteria:
- End-stage kidney disease stage V
- Patients with AKI in the 7 days prior to surgery
- Interstitial glomerulonephritis or vasculitis
- Pregnancy
- Kidney transplant
- Endocarditis
- Patients with mechanical assistance devices (ECMO, LVAD, RVAD, IABP)
- Inclusion in another clinical intervention test during the intervention period
- Emergence surgery
- Patients in need of pressure-directed therapy of cerebral infusion.
- Constrictive pericarditis
| Contact: Alícia Molina Andújar, MD | 932 27 54 00 ext 2050 | amolinaa@clinic.cat |
| Spain | |
| Hospital Clinic de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Alícia Molina Andújar, MD 932 275 400 ext 2050 amolinaa@clinic.cat | |
| Principal Investigator: | Esteban Poch, PhD, MD | Hospital Clinic of Barcelona |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 27, 2019 | ||||
| First Posted Date ICMJE | July 2, 2019 | ||||
| Last Update Posted Date | April 21, 2021 | ||||
| Actual Study Start Date ICMJE | October 14, 2019 | ||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
AKI incidence [ Time Frame: 18 months ] Reduction in the incidence of AKI
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acute Post-cardiac Surgery Renal Failure: Prevention Through Individualized Intensive Hemodynamic Management | ||||
| Official Title ICMJE | Acute Post-cardiac Surgery Renal Failure: Prevention Through Individualized Intensive Hemodynamic Management and Evaluation of Prognostic Biomarkers | ||||
| Brief Summary |
BACKGROUND: The incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery can reach 35% and between 2 and 5% require kidney replacement therapy during the AKI episode. The development of AKI n this context is independently associated with higher long-term mortality (5-10 years). In addition, there is strong evidence that an episode of AKI in the hospital increases the risk of developing chronic kidney disease in the medium-long term. On the other hand, once AKI has been recovered according to creatinine values, there are no established biomarkers to predict patients at risk of progression to chronic kidney disease, which will allow us to increase nephroprotection and surveillance measures in this group of patients. STUDY DESIGN: Open-label randomized unicentric prospective study of patients undergoing valvular replacement heart surgery ± coronary bypass with acute kidney injury (AKI) risk >30% according to the Leicester Cardiosurgery scale. Patients will be randomized 1:1 in two groups: standard hemodynamic management or intensive hemodynamic management based on premorbid mean perfusion pressure (MPP). The interventional period will span from intra-operation until the first 24 hours postoperative. The incidence of AKI will be evaluated according to KDIGO criteria between 48 hours and 7 days after surgery. Patients will be followed for one year. Biomarkers of mitochondrial damage will be analyzed at various points during the follow-up to patients presenting AKI. INTERVENTIONS: A) Group 1/Intensive management: Intra-surgical values of ± 25% basal MAP will be maintained and once in the ICU an algorithm corresponding to group 1 based on cardiac index and ± 25% MPP will be followed for 24 hours. B) Group 2/Standard management: MAP during surgery will be maintained > 60 mmHg according to usual protocol. Once in ICU, during the first 24 hours an algorithm corresponding to group 2 based on cardiac index, MAP and CVP will be followed. Biomarkers of mitochondrial damage will be determined in urine in patients in both groups only in patients developing AKI according to KDIGO guidelines between 48h and 7 days. EXPECTED RESULTS:A 50% reduction in the incidence of AKI in the intervention group compared to the control group is expected. At the same time, markers of mitochondrial damage are expected to be validated in our cohort as biomarkers of AKI progression and to investigate its usefulness as biomarkers of transition to Chronic kidney disease. |
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| Detailed Description |
BACKGROUND: The incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery can reach 35% and between 2 and 5% require kidney replacement therapy during the AKI episode. The development of AKI n this context is independently associated with higher long-term mortality (5-10 years). In addition, there is strong evidence that an episode of AKI in the hospital increases the risk of developing chronic kidney disease in the medium-long term. That is why the prevention of AKI is essential to reduce the morbidity that these patients suffer in the hospital and out-of-hospital environment. On the other hand, once AKI has been recovered according to creatinine values, there are no established biomarkers to predict patients at risk of progression to chronic kidney disease, which will allow us to increase nephroprotection and surveillance measures in this group of patients. STUDY DESIGN: Open-label randomized unicentric prospective study of patients undergoing valvular replacement heart surgery ± coronary bypass with acute kidney injury (AKI) risk >30% according to the Leicester Cardiosurgery scale. Patients will be randomized 1:1 in two groups: standard hemodynamic management or intensive hemodynamic management based on premorbid mean perfusion pressure (MPP). The interventional period will span from intra-operation until the first 24 hours postoperative. The incidence of AKI will be evaluated according to KDIGO criteria between 48 hours and 7 days after surgery. Patients will be followed for one year. Biomarkers of mitochondrial damage will be analyzed at various points during the follow-up to patients presenting AKI. Intention to treat population will be defined as patients who sign informed consent and undergo planned surgery. INTERVENTIONS-ANALYSIS: A) Group 1/Intensive management: Baseline mean blood pressure (MAP) and central venous pressure (CVP) will be measured to calculate baseline mean perfusion pressure (MPP). Intra-surgical values of ± 25% basal MAP will be maintained and once in the ICU an algorithm corresponding to group 1 based on cardiac index and ± 25% MPP will be followed for 24 hours. B) Group 2/Standard management: MAP during surgery will be maintained > 60 mmHg according to usual protocol. Once in ICU, during the first 24 hours an algorithm corresponding to group 2 based on cardiac index, MAP and CVP will be followed. Biomarkers of mitochondrial damage will be determined in urine in patients in both groups only in patients developing AKI according to KDIGO guidelines between 48h and 7 days. The following variables will be assessed in both groups: accumulated fluid balance in first 24 hours, ICU /hospitalization length of stay, days with vasoactive support, MAKE (Major Adverse Kidney Events: mortality, need for renal replacement therapy, persistent renal dysfunction) at 30, 90 and 365 days and other AKI episodes at one year. In the patients who develop AKI, urinary markers of mitochondrial injury will also be measured at 30 days. EXPECTED RESULTS: A 50% reduction in the incidence of AKI in the intervention group compared to the control group is expected. At the same time, markers of mitochondrial damage are expected to be validated in our cohort as biomarkers of AKI progression and to investigate its usefulness as biomarkers of transition to Chronic kidney disease. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Acute Kidney Injury | ||||
| Intervention ICMJE | Behavioral: Intensive management
Management based on premorbid MAP and MPP
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
240 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 1, 2022 | ||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04005105 | ||||
| Other Study ID Numbers ICMJE | PrevHemAKI | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Esteban Poch, Hospital Clinic of Barcelona | ||||
| Study Sponsor ICMJE | Hospital Clinic of Barcelona | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Hospital Clinic of Barcelona | ||||
| Verification Date | April 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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