Timing of RRT in Mechanically Ventilated PatientsNCT05382598
Timing of Renal Replacement Therapy In Mechanically Ventilated Patients
A study testing Renal replacement therapy in people with Timing of RRT in Mechanically Ventilated Patients, run by Alexandria University at 1 site in Egypt.
Trial summary
This is a randomized controlled study that will be conducted on acute kidney injury (AKI) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (RRT) compared to late RRT on patients outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Timing of RRT in Mechanically Ventilated Patients
- What is being tested?
- Renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2022to 28 Nov 2023
- 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
- All patients must be on invasive mechanical ventilation.
- Patients in AKI stage 2 , according to KDIGO classification.
- Recruited subjects will include either those who present with AKI on their ICU admission or those who develop AKI during their ICU stay
Who cannot join
- Those who are known to be in grade 5 CKD according to KDIGO classification. All other grades of CKD from 1 to 4 will be included only if they develop or present with stage 2 AKI on top of their CKD grade
- Those who develop AKI due to obstructive or traumatic causes.
- Patients with septic shock who are on high doses of vasopressors or inotropes (norepinephrine infusion more than 1 mcg/kg/minute, dopamine or dobutamine infusion more than 5 mcg/kg/minute).
- Pregnant females
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alexandria Faculty of Medicine
Alexandria, Alexandria Governorate, 21131
About this study
Official title: Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury
This is a randomized controlled study that will be conducted on acute kidney injury (AKI) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (RRT) compared to late RRT on patients outcome.
Read the detailed description
The study subjects will be randomly divided into two groups (arms).
The first one will be patients who will receive early renal replacement therapy (RRT) according to predefined criteria that will be illustrated later.
The other group of patients will be those who receive late RRT according to the absolute indications of emergency hemodialysis i.e. severe hyperkalemia, life-threatening acidosis, uremic encephalopathy or pericarditis in addition to intractable pulmonary edema.
Appropriate randomization technique will be applied. A computer-based program will be used to perform the randomization procedure.
- Being tested
- Renal replacement therapy
- Keywords
- early and late RRT, AKI, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal replacement therapyProcedure or surgery
Renal replacement therapy (RRT) will be initiated in the early group for patients who have stage 2 AKI according to KDIGO classification. The late group will have RRT when they develop any of the absolute indications for RRT
| Study group | Role | What they receive |
|---|---|---|
| Early renal replacement therapy (RRT) group | Active comparator | In this group of patients, RRT will be initiated if the patient either presents with or develops AKI, while mechanically ventilated, provided that he is in stage 2 according to KDIGO classification.
RRT will not be delayed till the presence of an urgent indication for the procedure.
A trial of furosemide stress test will be applied before proceeding towards early RRT after volume optimization. Receives: Procedure: Renal replacement therapy |
| Late renal replacement therapy (RRT) group | Active comparator | This group of patients will receive RRT if they develop any of the following indications:
* Severe hyperkalemia (> 6.5 mEq/L).
* Oliguria with failed response to diuretics in the presence of life-threatening pulmonary edema requiring high ventilatory settings i.e. PEEP >10 in addition to FiO2 > 50%.
* Severe metabolic acidosis (PH <7.15).
* Uremic pericarditis, encephalopathy or coagulopathy. Receives: Procedure: Renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
ICU mortality
Measured: 28 days
ICU length of stay
Duration of ICU stay
Measured: through study completion, an average of 1 year
Weaning of mechanical ventilation
duration of mechanical ventilation
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
RRT dependency
Persistent need for renal replacement therapy for at least two sessions per week
Measured: for more than three months
Renal functions on discharge from ICU
creatinine level on day of discharge from ICU
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start28 Jun 2022
- Primary completion20 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Timing of RRT in Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr M Elsharkawy, Master, Principal investigator, Alexandria Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382598
- Sponsor's protocol ID
- 4220
- Status last verified
- Nov 2023
- First submitted
- 17 Apr 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas ME, Blaine C, Dawnay A, Devonald MA, Ftouh S, Laing C, Latchem S, Lewington A, Milford DV, Ostermann M. The definition of acute kidney injury and its use in practice. Kidney Int. 2015 Jan;87(1):62-73. doi: 10.1038/ki.2014.328. Epub 2014 Oct 15.
PubMed 25317932Kellum JA, Lameire N, Aspelin P, Barsoum RS, Burdmann EA, Goldstein SL, et al. Kidney disease: Improving global outcomes (KDIGO) acute kidney injury work group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int Suppl 2012;2:1-138
Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int. 2021 Mar;99(3S):S1-S87. doi: 10.1016/j.kint.2020.11.003. No abstract available.
PubMed 33637192Gaudry S, Hajage D, Benichou N, Chaibi K, Barbar S, Zarbock A, Lumlertgul N, Wald R, Bagshaw SM, Srisawat N, Combes A, Geri G, Jamale T, Dechartres A, Quenot JP, Dreyfuss D. Delayed versus early initiation of renal replacement therapy for severe acute kidney injury: a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet. 2020 May 9;395(10235):1506-1515. doi: 10.1016/S0140-6736(20)30531-6. Epub 2020 Apr 23.
PubMed 32334654Wald R, Bagshaw SM. The timing of renal replacement therapy initiation in acute kidney injury: is earlier truly better?*. Crit Care Med. 2014 Aug;42(8):1933-4. doi: 10.1097/CCM.0000000000000432. No abstract available.
PubMed 25029128Besen BAMP, Romano TG, Mendes PV, Gallo CA, Zampieri FG, Nassar AP Jr, Park M. Early Versus Late Initiation of Renal Replacement Therapy in Critically Ill Patients: Systematic Review and Meta-Analysis. J Intensive Care Med. 2019 Sep;34(9):714-722. doi: 10.1177/0885066617710914. Epub 2017 Jun 1.
PubMed 28569129Yang XM, Tu GW, Zheng JL, Shen B, Ma GG, Hao GW, Gao J, Luo Z. A comparison of early versus late initiation of renal replacement therapy for acute kidney injury in critically ill patients: an updated systematic review and meta-analysis of randomized controlled trials. BMC Nephrol. 2017 Aug 7;18(1):264. doi: 10.1186/s12882-017-0667-6.
PubMed 28784106Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
PubMed 24053972Stawicki SP, Braslow BM, Panebianco NL, Kirkpatrick JN, Gracias VH, Hayden GE, Dean AJ. Intensivist use of hand-carried ultrasonography to measure IVC collapsibility in estimating intravascular volume status: correlations with CVP. J Am Coll Surg. 2009 Jul;209(1):55-61. doi: 10.1016/j.jamcollsurg.2009.02.062. Epub 2009 May 1.
PubMed 19651063Bersten AD, Handy JM. Oh's intensive care manual. 8th ed. Oxford, U.K.: Elsevier; 2018.
Fink MP, Vincent JL, Abraham E, Moore FA, Kochanek P. Textbook of critical care. 7th ed. Philadelphia, PA: Elsevier; 2016.
Turner N, Lameire N, Goldsmith DJ, Winearls CG, Himmelfarb J, Remuzzi G. Oxford textbook of clinical nephrology. 4th ed. Oxford, United Kingdom: Oxford University Press; 2016.
Goldsmith D, Jayawardene S, Ackland P. ABC of kidney disease. 2nd ed. United Kingdom : BMJ Books; 2013.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05382598
- Acronym / sponsor ID
- 4220
- Keywords
- early and late RRT, AKI, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 19 May 2022 (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.
This is a randomized controlled study that will be conducted on acute kidney injury (AKI) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (RRT) compared to late RRT on patients outcome.
Detailed description
The study subjects will be randomly divided into two groups (arms).
The first one will be patients who will receive early renal replacement therapy (RRT) according to predefined criteria that will be illustrated later.
The other group of patients will be those who receive late RRT according to the absolute indications of emergency hemodialysis i.e. severe hyperkalemia, life-threatening acidosis, uremic encephalopathy or pericarditis in addition to intractable pulmonary edema.
Appropriate randomization technique will be applied. A computer-based program will be used to perform the randomization procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early renal replacement therapy (RRT) group | Active comparator | Procedure: Renal replacement therapyIn this group of patients, RRT will be initiated if the patient either presents with or develops AKI, while mechanically ventilated, provided that he is in stage 2 according to KDIGO classification. RRT will not be delayed till the presence of an urgent indication for the procedure. A trial of furosemide stress test will be applied before proceeding towards early RRT after volume optimization. |
| Late renal replacement therapy (RRT) group | Active comparator | Procedure: Renal replacement therapyThis group of patients will receive RRT if they develop any of the following indications: * Severe hyperkalemia (> 6.5 mEq/L). * Oliguria with failed response to diuretics in the presence of life-threatening pulmonary edema requiring high ventilatory settings i.e. PEEP >10 in addition to FiO2 > 50%. * Severe metabolic acidosis (PH <7.15). * Uremic pericarditis, encephalopathy or coagulopathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients must be on invasive mechanical ventilation.
- Patients in AKI stage 2 , according to KDIGO classification.
- Recruited subjects will include either those who present with AKI on their ICU admission or those who develop AKI during their ICU stay
Key exclusion criteria (4 listed)
- Those who are known to be in grade 5 CKD according to KDIGO classification. All other grades of CKD from 1 to 4 will be included only if they develop or present with stage 2 AKI on top of their CKD grade
- Those who develop AKI due to obstructive or traumatic causes.
- Patients with septic shock who are on high doses of vasopressors or inotropes (norepinephrine infusion more than 1 mcg/kg/minute, dopamine or dobutamine infusion more than 5 mcg/kg/minute).
- Pregnant females
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 |
|---|---|---|
| Renal replacement therapyRenal replacement therapy (RRT) will be initiated in the early group for patients who have stage 2 AKI according to KDIGO classification. The late group will have RRT when they develop any of the absolute indications for RRT | Procedure or surgery | Early renal replacement therapy (RRT) group, Late renal replacement therapy (RRT) group |
Primary outcome
mortality
Time frame: 28 days
ICU mortality
ICU length of stay
Time frame: through study completion, an average of 1 year
Duration of ICU stay
Weaning of mechanical ventilation
Time frame: through study completion, an average of 1 year
duration of mechanical ventilation
2 secondary outcomes
RRT dependency
Time frame: for more than three months
Renal functions on discharge from ICU
Time frame: through study completion, an average of 1 year
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 4 Dec 2023.
- Results publication: PubMed 25317932Thomas ME, Blaine C, Dawnay A, Devonald MA, Ftouh S, Laing C, Latchem S, Lewington A, Milford DV, Ostermann M. The definition of acute kidney injury and its use in practice. Kidney Int. 2015 Jan;87(1):62-73. doi: 10.1038/ki.2014.328. Epub 2014 Oct 15.
- Results publicationKellum JA, Lameire N, Aspelin P, Barsoum RS, Burdmann EA, Goldstein SL, et al. Kidney disease: Improving global outcomes (KDIGO) acute kidney injury work group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int Suppl 2012;2:1-138
- Results publication: PubMed 33637192Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int. 2021 Mar;99(3S):S1-S87. doi: 10.1016/j.kint.2020.11.003. No abstract available.
- Results publication: PubMed 32334654Gaudry S, Hajage D, Benichou N, Chaibi K, Barbar S, Zarbock A, Lumlertgul N, Wald R, Bagshaw SM, Srisawat N, Combes A, Geri G, Jamale T, Dechartres A, Quenot JP, Dreyfuss D. Delayed versus early initiation of renal replacement therapy for severe acute kidney injury: a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet. 2020 May 9;395(10235):1506-1515. doi: 10.1016/S0140-6736(20)30531-6. Epub 2020 Apr 23.
- Results publication: PubMed 25029128Wald R, Bagshaw SM. The timing of renal replacement therapy initiation in acute kidney injury: is earlier truly better?*. Crit Care Med. 2014 Aug;42(8):1933-4. doi: 10.1097/CCM.0000000000000432. No abstract available.
- Results publication: PubMed 28569129Besen BAMP, Romano TG, Mendes PV, Gallo CA, Zampieri FG, Nassar AP Jr, Park M. Early Versus Late Initiation of Renal Replacement Therapy in Critically Ill Patients: Systematic Review and Meta-Analysis. J Intensive Care Med. 2019 Sep;34(9):714-722. doi: 10.1177/0885066617710914. Epub 2017 Jun 1.
- Results publication: PubMed 28784106Yang XM, Tu GW, Zheng JL, Shen B, Ma GG, Hao GW, Gao J, Luo Z. A comparison of early versus late initiation of renal replacement therapy for acute kidney injury in critically ill patients: an updated systematic review and meta-analysis of randomized controlled trials. BMC Nephrol. 2017 Aug 7;18(1):264. doi: 10.1186/s12882-017-0667-6.
- Results publication: PubMed 24053972Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
- Results publication: PubMed 19651063Stawicki SP, Braslow BM, Panebianco NL, Kirkpatrick JN, Gracias VH, Hayden GE, Dean AJ. Intensivist use of hand-carried ultrasonography to measure IVC collapsibility in estimating intravascular volume status: correlations with CVP. J Am Coll Surg. 2009 Jul;209(1):55-61. doi: 10.1016/j.jamcollsurg.2009.02.062. Epub 2009 May 1.
- Results publicationBersten AD, Handy JM. Oh's intensive care manual. 8th ed. Oxford, U.K.: Elsevier; 2018.
- Results publicationFink MP, Vincent JL, Abraham E, Moore FA, Kochanek P. Textbook of critical care. 7th ed. Philadelphia, PA: Elsevier; 2016.
- Results publicationTurner N, Lameire N, Goldsmith DJ, Winearls CG, Himmelfarb J, Remuzzi G. Oxford textbook of clinical nephrology. 4th ed. Oxford, United Kingdom: Oxford University Press; 2016.
- Individual participant dataSharing planned: No
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.
Amr M Elsharkawy, Master principal investigator
Alexandria Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal replacement therapy in people with Timing of RRT in Mechanically Ventilated Patients, run by Alexandria University at 1 site in Egypt.
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 4 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 4 Dec 2023. 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 Egypt. 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?
mortality (time frame: 28 days). The study lists 3 primary outcomes in all. 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 NCT05382598, which also lists 13 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 4 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.