Septic Acute Kidney InjuryNCT04222361
KDIGO Bundle to Prevent AKI in Sepsis
A study testing Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI in people with Septic Acute Kidney Injury, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Acute Kidney Injury
- What is being tested?
- Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Patients (or their informed family members) who accept and sign the informed consent.
- Patients diagnosed with sepsis or abdominal post-surgical septic shock.
Who cannot join
- Patients under 18 years.
- Patients (or their authorized relatives) who refuse to sign the informed consent.
- Patients diagnosed with sepsis or non-surgical septic shock.
- Patients diagnosed with sepsis or septic shock of origin other than abdominal.
- Patients with AKI stages KDIGO 2 and 3 and / or renal replacement therapy.
- Patients with chronic renal failure and glomerular filtration <30 ml / min and / or undergoing treatment with dialysis or previous renal transplantation.
- Patients with AKI of origin other than the diagnosed septic, such as glomerulonephritis or interstitial nephritis, renal artery occlusion and / or postrenal obstruction.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Surgical Intensive Care Unit of the General University Hospital of Elche
Elche, Alicante, 03203
Ana Perez Carbonell, MD, PhD, +34605266485, perez_anacar@gva.es
About this study
Official title: Prevention of Acute Renal Injury in the Septic Patient by Implementing the KDIGO Guideline in High-risk Patients Identified by Biomarkers
Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by NephroCheck® Test that integrates the urinary biomarkers TIMP-2 and IGFBP-7.
Hypothesis: The implementation of a package of preventive measures proposed by the KDIGO guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.
- Conditions
- Septic Acute Kidney Injury
- Being tested
- Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKIProcedure or surgery
Patients assigned to the treatment group will receive the AKI preventive recommendations from the KDIGO guide: withdraw nephrotoxics, ensure volemia and renal perfusion pressure by means of advanced hemodynamic monitoring-optimization (minimum monitoring objective: Unit algorithm based on volume systolic (VS) by pulse wave analysis - Flotrac® / ClearSight® system - or transpulmonary thermodilution - VolumeView® system -), monitor plasma creatinine and urinary expenditure, avoid hyperglycemia (serum blood glucose target: 110-149 mg / dl), and consider alternatives to diagnostic-therapeutic radiocontrast procedures.
| Study group | Role | What they receive |
|---|---|---|
| KDIGO guide recommendations | Experimental | Preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI Receives: Procedure: Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI |
| Standard care | No intervention | The patients assigned to the control group will receive the current standard care of the septic patients of the Unit according to our protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the incidence of moderate-severe acute renal injury
Compare the incidence of moderate-severe acute renal injury (stages KDIGO 2 and 3) in the first 72 hours of diagnosis of sepsis and septic post-surgical septic shock in patients at high risk of AKI determined by NephroCheck® Test (those with a ≥0.3 ng / ml2 / 1000 result) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
Measured: 72 hours
Secondary outcomes (6)
Compare mortality from any cause
Compare mortality from any cause at 12, 24, 48 and 72 hours, and 30, 60 and 90 days in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (patients with results ≥0.3 ng / ml2 / 1000) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
Measured: 90 days
Compare the number of participants in need of renal replacement therapy
Compare the number of participants in need of renal replacement therapy at 12, 24, 48 and 72 hours, and 30, 60 and 90 days in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with result ≥0.3 ng / ml2 / 1000) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
Measured: 90 days
Compare the number of participants with persistent renal dysfunction
Compare the number of participants with persistent renal dysfunction at 30, 60 and 90 days in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with a ≥0.3 ng / ml2 / 1000 result) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
Measured: 90 days
Compare the number of days of stay in the Surgical ICU
Compare the number of days of stay in the Surgical ICU in patients diagnosed with sepsis and septic post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with a result ≥0.3 ng / ml2 / 1000) that apply the package of preventive measures proposed by the guide KDIGO vs. standard treatment
Measured: 90 days
Compare the number of days of stay in the hospital
Compare the number of days of stay in the hospital in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with a result ≥0.3 ng / ml2 / 1000) that apply the package of preventive measures proposed by the KDIGO guide vs. standard treatment
Measured: 90 days
Measure the incidence of development of AKI in patients at low risk of AKI determined by NephroCheck® Test
Measure the incidence of development of AKI (any KDIGO stage) at 12, 24, 48 and 72 hours after diagnosis of sepsis and septic post-surgical septic shock in patients at low risk of AKI determined by NephroCheck® Test (those with a result of 0.3 ng / ml2 / 1000).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study startOct 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Mercader Alarcón, Hospital General Universitario Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222361
- Sponsor's protocol ID
- PI 42/2018
- Status last verified
- Jul 2020
- First submitted
- 4 Jan 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Renal Injury in the Septic Patient by Implementing the KDIGO Guideline in High-risk Patients Identified by Biomarkers
- ClinicalTrials.gov ID
- NCT04222361
- Acronym / sponsor ID
- PI 42/2018
- Conditions
- Septic Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by NephroCheck® Test that integrates the urinary biomarkers TIMP-2 and IGFBP-7.
Hypothesis: The implementation of a package of preventive measures proposed by the KDIGO guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KDIGO guide recommendations | Experimental | Procedure: Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKIPreventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI |
| Standard care | No intervention | –The patients assigned to the control group will receive the current standard care of the septic patients of the Unit according to our protocols |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years.
- Patients (or their informed family members) who accept and sign the informed consent.
- Patients diagnosed with sepsis or abdominal post-surgical septic shock.
Key exclusion criteria (7 listed)
- Patients under 18 years.
- Patients (or their authorized relatives) who refuse to sign the informed consent.
- Patients diagnosed with sepsis or non-surgical septic shock.
- Patients diagnosed with sepsis or septic shock of origin other than abdominal.
- Patients with AKI stages KDIGO 2 and 3 and / or renal replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKIPatients assigned to the treatment group will receive the AKI preventive recommendations from the KDIGO guide: withdraw nephrotoxics, ensure volemia and renal perfusion pressure by means of advanced hemodynamic monitoring-optimization (minimum monitoring objective: Unit algorithm based on volume systolic (VS) by pulse wave analysis - Flotrac® / ClearSight® system - or transpulmonary thermodilution - VolumeView® system -), monitor plasma creatinine and urinary expenditure, avoid hyperglycemia (serum blood glucose target: 110-149 mg / dl), and consider alternatives to diagnostic-therapeutic radiocontrast procedures. | Procedure or surgery | KDIGO guide recommendations |
Primary outcome
Compare the incidence of moderate-severe acute renal injury
Time frame: 72 hours
Compare the incidence of moderate-severe acute renal injury (stages KDIGO 2 and 3) in the first 72 hours of diagnosis of sepsis and septic post-surgical septic shock in patients at high risk of AKI determined by NephroCheck® Test (those with a ≥0.3 ng / ml2 / 1000 result) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
6 secondary outcomes
Compare mortality from any cause
Time frame: 90 days
Compare the number of participants in need of renal replacement therapy
Time frame: 90 days
Compare the number of participants with persistent renal dysfunction
Time frame: 90 days
Compare the number of days of stay in the Surgical ICU
Time frame: 90 days
Compare the number of days of stay in the hospital
Time frame: 90 days
Measure the incidence of development of AKI in patients at low risk of AKI determined by NephroCheck® Test
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI in people with Septic Acute Kidney Injury, run by Hospital General Universitario Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Mercader Alarcon, MD, DESA (+34696195678, mariamercader@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the incidence of moderate-severe acute renal injury (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.