Timing of Renal Replacement Therapy In Mechanically Ventilated Patients
NCT ID: NCT05382598
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2022-06-28
2023-11-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early renal replacement therapy (RRT) group
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.
Renal replacement therapy
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
Late renal replacement therapy (RRT) group
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.
Renal replacement therapy
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
Interventions
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Renal replacement therapy
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Principal Investigators
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Amr M Elsharkawy, Master
Role: PRINCIPAL_INVESTIGATOR
Alexandria Faculty of Medicine
Locations
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Alexandria Faculty of Medicine
Alexandria, Alexandria Governorate, Egypt
Countries
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References
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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.
Kellum 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.
Gaudry 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.
Wald 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.
Besen 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.
Yang 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.
Chawla 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.
Stawicki 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.
Bersten 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.
Other Identifiers
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4220
Identifier Type: -
Identifier Source: org_study_id