Renal Replacement Therapy for Acute Kidney Injury in Intensive Care UnitAKIKINCT01932190
Artificial Kidney Initiation in Kidney Injury
A study testing Early RRT strategy and Delayed RRT strategy in people with Renal Replacement Therapy for Acute Kidney Injury in Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy for Acute Kidney Injury in Intensive Care Unit
- What is being tested?
- Early RRT strategy and Delayed RRT strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute renal failure due to:
- urinary tract obstruction
- renal vessels obstruction
- tumor lysis syndrome
- thrombotic microangiopathy
- acute glomerulonephritis
Show all 18Show fewer
- Intoxication with a dialyzable product
- Child-Pugh class C liver cirrhosis
- Renal transplant
- Cardiac arrest without awakening at time of potential inclusion
- Moribund state
- Decision to limit treatment
- RRT already started for the current episode of AKI
- Presenting (at the time of potential inclusion) a strong indication for immediate RRT
- oligoanuria for more than 3 days
- serum urea concentration > 40 mmol / l serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
- Under cardiopulmonary bypass
- Included in another clinical trial on RRT modalities.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial
The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:
- an "early" strategy where RRT is started immediately when a RIFLE F status is documented
- a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
Read the detailed description
Background:
Acute kidney injury (AKI) is a common complication in intensive care unit (ICU) patients. Renal replacement therapy (RRT) is the major supportive treatment of AKI. Despite progress in RRT management, mortality remains high and the timing of its initiation remains open to debate when no metabolic disorder (severe hyperkalemia or metabolic acidosis) or major fluid overload threaten short-term prognosis. Such abnormalities mandate RRT and are non-inclusion criteria of our study. Whereas many studies have focused on RRT modalities, no prospective randomized study has evaluated the criteria for initiating RRT in ICU in the absence of the above-mentioned life-threatening disorders. In other words, whether duration of oliguria/anuria and/or value of serum urea/creatinine are an adequate indication for RRT is unknown. Given the lack of high quality data, it is not surprising that survey of practices showed wide variation in the timing of RRT initiation and that no precise guidelines could be drawn by expert recommendation as to the optimal start of RRT, making a randomised controlled study of timing of RRT both desirable and ethical.
Objective:
The main objective of this study is to compare two strategies of RRT initiation in terms of overall survival in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:
- an "early" strategy where RRT is started immediately when a RIFLE F status is documented
- a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
Design:
Prospective, multicenter, randomized, open-label trial comparing two RRT initiation strategies in terms of overall survival.
Primary endpoint:
Overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
Secondary endpoints:
Survival rate at day 28, percentage of patients requiring who did not require RRT in the "delayed" strategy, time until cessation of RRT therapy, rate of adverse events potentially related to the AKI or to RRT (e.g; RRT catheter-related complications, hemorrhage due to anticoagulation required for RRT etc…), rate of nosocomial infections, number of ventilator-free days of RRT-free days and of vasopressors free days, length of stay in ICU and hospital, rate of limitations of treatment for futility, total cost of consumables (including RRT catheters and lines among others) related to RRT between day 1 and day 28.
Number of subjects required:
We hypothesized that the "delayed" strategy would prove beneficial to the patients and would translate into increased survival. The study is designed to prove superiority (and not noninferiority) of this strategy over the "early" one.
The 60 days survival rate with the "early" strategy is estimated to be 45%. It is necessary to include 620 patients (310 per arm) to obtain a power of 90% to detect a survival improvement of 14% at day 60 with the "delayed" strategy (log-rank two tailed test, global significance level of 5%), with two blind interim analyses by independent observers at 90 and 180 deaths (group sequential approach of O'Brien-Fleming), and a estimated dropout rate of 10%.
Duration of study:
Inclusion: 18 months Minimum participation of each patient: 60 days Analysis and report: 10 months
- Being tested
- Early RRT strategy, Delayed RRT strategy
- Keywords
- Acute Kidney Injury, Critical Care, Renal Replacement Therapy, Treatment Outcome
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early RRT strategyProcedure or surgery
the "early" strategy : RRT is started immediately when a RIFLE F status is documented
Delayed RRT strategyProcedure or surgery
The "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria": see summary
| Study group | Role | What they receive |
|---|---|---|
| Early RRT strategy | Experimental | the "early" strategy : RRT is started immediately when a RIFLE F status is documented Receives: Procedure: Early RRT strategy |
| Delayed RRT strategy | Experimental | The "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria" Receives: Procedure: Delayed RRT strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
Measured: 60 days
Secondary outcomes (11)
Survival rate
Survival rate at day 28
Measured: 28 days
percentage of patients requiring at least a RRT in the "waiting" strategy
Measured: 28 days
time to withdrawal RRT
Measured: 28 days
rate of adverse events potentially related to the AKI or RRT
Measured: 28 days
rate of nosocomial infections
Measured: 28 days
rate of ventilator free days
Measured: 28 days
rate of RRT free days
Measured: 28 days
rate of vasopressors free days
Measured: 28 days
length of stay in ICU and hospital
Measured: 60 days
rate of limitations of treatment
Measured: 28 days
total cost of consumables related to RRT
total cost of consumables related to RRT between day 1 and day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal Replacement Therapy for Acute Kidney Injury in Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier DREYFUSS, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932190
- Sponsor's protocol ID
- AOM12456 - K120102
- Other IDs
- 2013-A00765-40
- Acronym
- AKIKI
- Status last verified
- Aug 2013
- First submitted
- 27 Aug 2013
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Roux D, Benichou N, Hajage D, Martin-Lefevre L, de Prost N, Lerolle N, Titeca-Beauport D, Boulet E, Mayaux J, Megarbane B, Mahjoub K, Carpentier D, Nseir S, Tubach F, Ricard JD, Dreyfuss D, Gaudry S; AKIKI Study group. Impact of renal replacement therapy strategy on beta-lactam plasma concentrations: the BETAKIKI study-an ancillary study of a randomized controlled trial. Ann Intensive Care. 2023 Feb 25;13(1):11. doi: 10.1186/s13613-023-01105-0.
PubMed 36840825Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
PubMed 36416787Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Verney C, Pons B, Boulet E, Boyer A, Chevrel G, Lerolle N, Carpentier D, de Prost N, Lautrette A, Bretagnol A, Mayaux J, Nseir S, Megarbane B, Thirion M, Forel JM, Maizel J, Yonis H, Markowicz P, Thiery G, Tubach F, Ricard JD, Dreyfuss D. Timing of Renal Support and Outcome of Septic Shock and Acute Respiratory Distress Syndrome. A Post Hoc Analysis of the AKIKI Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):58-66. doi: 10.1164/rccm.201706-1255OC.
PubMed 29351007Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, Boyer A, Chevrel G, Lerolle N, Carpentier D, de Prost N, Lautrette A, Bretagnol A, Mayaux J, Nseir S, Megarbane B, Thirion M, Forel JM, Maizel J, Yonis H, Markowicz P, Thiery G, Tubach F, Ricard JD, Dreyfuss D; AKIKI Study Group. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33. doi: 10.1056/NEJMoa1603017. Epub 2016 May 15.
PubMed 27181456Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Tubach F, Pons B, Boulet E, Boyer A, Lerolle N, Chevrel G, Carpentier D, Lautrette A, Bretagnol A, Mayaux J, Thirion M, Markowicz P, Thomas G, Dellamonica J, Richecoeur J, Darmon M, de Prost N, Yonis H, Megarbane B, Loubieres Y, Blayau C, Maizel J, Zuber B, Nseir S, Bige N, Hoffmann I, Ricard JD, Dreyfuss D. Comparison of two strategies for initiating renal replacement therapy in the intensive care unit: study protocol for a randomized controlled trial (AKIKI). Trials. 2015 Apr 17;16:170. doi: 10.1186/s13063-015-0718-x.
PubMed 25902813
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial
- ClinicalTrials.gov ID
- NCT01932190
- Acronym / sponsor ID
- AKIKI / AOM12456 - K120102
- Keywords
- Acute Kidney Injury, Critical Care, Renal Replacement Therapy, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Aug 2013 (estimated)
- 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.
The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:
- an "early" strategy where RRT is started immediately when a RIFLE F status is documented
- a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
Detailed description
Background:
Acute kidney injury (AKI) is a common complication in intensive care unit (ICU) patients. Renal replacement therapy (RRT) is the major supportive treatment of AKI. Despite progress in RRT management, mortality remains high and the timing of its initiation remains open to debate when no metabolic disorder (severe hyperkalemia or metabolic acidosis) or major fluid overload threaten short-term prognosis. Such abnormalities mandate RRT and are non-inclusion criteria of our study. Whereas many studies have focused on RRT modalities, no prospective randomized study has evaluated the criteria for initiating RRT in ICU in the absence of the above-mentioned life-threatening disorders. In other words, whether duration of oliguria/anuria and/or value of serum urea/creatinine are an adequate indication for RRT is unknown. Given the lack of high quality data, it is not surprising that survey of practices showed wide variation in the timing of RRT initiation and that no precise guidelines could be drawn by expert recommendation as to the optimal start of RRT, making a randomised controlled study of timing of RRT both desirable and ethical.
Objective:
The main objective of this study is to compare two strategies of RRT initiation in terms of overall survival in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:
- an "early" strategy where RRT is started immediately when a RIFLE F status is documented
- a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
Design:
Prospective, multicenter, randomized, open-label trial comparing two RRT initiation strategies in terms of overall survival.
Primary endpoint:
Overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
Secondary endpoints:
Survival rate at day 28, percentage of patients requiring who did not require RRT in the "delayed" strategy, time until cessation of RRT therapy, rate of adverse events potentially related to the AKI or to RRT (e.g; RRT catheter-related complications, hemorrhage due to anticoagulation required for RRT etc…), rate of nosocomial infections, number of ventilator-free days of RRT-free days and of vasopressors free days, length of stay in ICU and hospital, rate of limitations of treatment for futility, total cost of consumables (including RRT catheters and lines among others) related to RRT between day 1 and day 28.
Number of subjects required:
We hypothesized that the "delayed" strategy would prove beneficial to the patients and would translate into increased survival. The study is designed to prove superiority (and not noninferiority) of this strategy over the "early" one.
The 60 days survival rate with the "early" strategy is estimated to be 45%. It is necessary to include 620 patients (310 per arm) to obtain a power of 90% to detect a survival improvement of 14% at day 60 with the "delayed" strategy (log-rank two tailed test, global significance level of 5%), with two blind interim analyses by independent observers at 90 and 180 deaths (group sequential approach of O'Brien-Fleming), and a estimated dropout rate of 10%.
Duration of study:
Inclusion: 18 months Minimum participation of each patient: 60 days Analysis and report: 10 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early RRT strategy | Experimental | Procedure: Early RRT strategythe "early" strategy : RRT is started immediately when a RIFLE F status is documented |
| Delayed RRT strategy | Experimental | Procedure: Delayed RRT strategyThe "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Acute renal failure due to:
- Intoxication with a dialyzable product
- Child-Pugh class C liver cirrhosis
- Renal transplant
- Cardiac arrest without awakening at time of potential inclusion
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Early RRT strategythe "early" strategy : RRT is started immediately when a RIFLE F status is documented | Procedure or surgery | Early RRT strategy |
| Delayed RRT strategyThe "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria": see summary | Procedure or surgery | Delayed RRT strategy |
Primary outcome
Overall survival
Time frame: 60 days
The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
11 secondary outcomes
Survival rate
Time frame: 28 days
percentage of patients requiring at least a RRT in the "waiting" strategy
Time frame: 28 days
time to withdrawal RRT
Time frame: 28 days
rate of adverse events potentially related to the AKI or RRT
Time frame: 28 days
rate of nosocomial infections
Time frame: 28 days
rate of ventilator free days
Time frame: 28 days
rate of RRT free days
Time frame: 28 days
rate of vasopressors free days
Time frame: 28 days
length of stay in ICU and hospital
Time frame: 60 days
rate of limitations of treatment
Time frame: 28 days
total cost of consumables related to RRT
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 36840825Roux D, Benichou N, Hajage D, Martin-Lefevre L, de Prost N, Lerolle N, Titeca-Beauport D, Boulet E, Mayaux J, Megarbane B, Mahjoub K, Carpentier D, Nseir S, Tubach F, Ricard JD, Dreyfuss D, Gaudry S; AKIKI Study group. Impact of renal replacement therapy strategy on beta-lactam plasma concentrations: the BETAKIKI study-an ancillary study of a randomized controlled trial. Ann Intensive Care. 2023 Feb 25;13(1):11. doi: 10.1186/s13613-023-01105-0.
- Derived from this study: PubMed 36416787Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
- Derived from this study: PubMed 29351007Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Verney C, Pons B, Boulet E, Boyer A, Chevrel G, Lerolle N, Carpentier D, de Prost N, Lautrette A, Bretagnol A, Mayaux J, Nseir S, Megarbane B, Thirion M, Forel JM, Maizel J, Yonis H, Markowicz P, Thiery G, Tubach F, Ricard JD, Dreyfuss D. Timing of Renal Support and Outcome of Septic Shock and Acute Respiratory Distress Syndrome. A Post Hoc Analysis of the AKIKI Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):58-66. doi: 10.1164/rccm.201706-1255OC.
- Derived from this study: PubMed 27181456Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, Boyer A, Chevrel G, Lerolle N, Carpentier D, de Prost N, Lautrette A, Bretagnol A, Mayaux J, Nseir S, Megarbane B, Thirion M, Forel JM, Maizel J, Yonis H, Markowicz P, Thiery G, Tubach F, Ricard JD, Dreyfuss D; AKIKI Study Group. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33. doi: 10.1056/NEJMoa1603017. Epub 2016 May 15.
- Derived from this study: PubMed 25902813Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Tubach F, Pons B, Boulet E, Boyer A, Lerolle N, Chevrel G, Carpentier D, Lautrette A, Bretagnol A, Mayaux J, Thirion M, Markowicz P, Thomas G, Dellamonica J, Richecoeur J, Darmon M, de Prost N, Yonis H, Megarbane B, Loubieres Y, Blayau C, Maizel J, Zuber B, Nseir S, Bige N, Hoffmann I, Ricard JD, Dreyfuss D. Comparison of two strategies for initiating renal replacement therapy in the intensive care unit: study protocol for a randomized controlled trial (AKIKI). Trials. 2015 Apr 17;16:170. doi: 10.1186/s13063-015-0718-x.
- Individual participant dataSharing planned: Undecided
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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.
Didier DREYFUSS, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early RRT strategy and Delayed RRT strategy in people with Renal Replacement Therapy for Acute Kidney Injury in Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 18 inclusion and 0 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: finished, as of the sponsor's last update on 24 Jun 2016. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932190, which also lists 5 linked publications.
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 24 Jun 2016.