AKI
ACT trial: Acetylcysteine for AKI protection
| Article Name: Acetylcysteine for Prevention of Renal Outcomes in Patients Undergoing Coronary and Peripheral Vascular Angiography |
| URL: https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.111.038943 |
| Journal and year of publication: Circulation, 2011 |
| Trial Design: Randomized clinical trial |
| Population: 2308 patients Key inclusion criteria: – Patients undergoing diagnostic intravascular angiography or PCI – At least 1 risk factor for contrast-induced AKI Key exclusion criteria: – On dialysis – ST-segment elevation myocardial infarction for primary angioplasty |
| Intervention Studied: Acetylcysteine |
| Control: Placebo |
| Outcomes: – Incidence of contrast-induced AKI: Acetylcysteine: 12.7% vs Placebo: 12.7% (P=0.97) The authors concluded that “In this large randomized trial, we found that acetylcysteine does not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in at-risk patients undergoing coronary and peripheral vascular angiography.” |
| Citation: ACT Investigators. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT). Circulation. 2011 Sep 13;124(11):1250-9. doi: 10.1161/CIRCULATIONAHA.111.038943. Epub 2011 Aug 22. PMID: 21859972. |
SALT-ED trial: IV fluid types for non-critically ill patients
| Article Name: Balanced Crystalloids versus Saline in Noncritically Ill Adults |
| URL: https://www.nejm.org/doi/full/10.1056/NEJMoa1711586 |
| Journal and year of publication: NEJM, 2018 |
| Trial Design: Randomized clinical trial |
| Population: 13,347 patients Key inclusion criteria: – Adults who received at least 500 ml of IV isotonic crystalloids in ED and were subsequently hospitalized outside an ICU Key exclusion criteria: |
| Intervention Studied: Balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A) |
| Control: Saline |
| Outcomes: – Incidence of major adverse kidney events (within 30 days): Balanced crystalloids: 4.7% vs Saline: 5.6% (P=0.01) – No difference in hospital-free days The authors concluded that “Among noncritically ill adults treated with intravenous fluids in the emergency department, there was no difference in hospital-free days between treatment with balanced crystalloids and treatment with saline.” |
| Citation: Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, Slovis CM, Lindsell CJ, Ehrenfeld JM, Siew ED, Shaw AD, Bernard GR, Rice TW; SALT-ED Investigators. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27. PMID: 29485926; PMCID: PMC5846618. |
IDEAL-ICU trial: Timing of dialysis for critically ill patients
| Article Name: Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis |
| URL: https://www.nejm.org/doi/full/10.1056/NEJMoa1803213 |
| Journal and year of publication: NEJM, 2018 |
| Trial Design: Randomized clinical trial |
| Population: 488 patients Key inclusion criteria: – Adults admitted to ICU in the early phase of septic shock (within 48 hours) – AKI meeting at least one of the criteria for the failure stage of RIFLE classification: Oliguria, anuria for 12 hours or more, or serum creatinine level 3 times the baseline level Key exclusion criteria: – End stage kidney disease on chronic RRT – Obstructive etiology for AKI |
| Intervention Studied: Early-strategy group (renal-replacement therapy within 12 hours) |
| Control: Delayed-strategy group (delay of 48 hours if renal recovery had not occurred) |
| Outcomes: – Death (within 90 days): Early-strategy group: 58% vs Delayed-strategy group: 54% (P=0.38) The authors concluded that “Among patients with septic shock who had severe acute kidney injury, there was no significant difference in overall mortality at 90 days between patients who were assigned to an early strategy for the initiation of renal-replacement therapy and those who were assigned to a delayed strategy.” |
| Citation: Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyère R, Lebert C, Bohé J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213. PMID: 30304656. |
CKD/ESRD
IDEAL trial: Timing of dialysis initiation
| Article Name: A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis |
| URL: https://www.nejm.org/doi/full/10.1056/NEJMoa1000552 |
| Journal and year of publication: NEJM, 2010 |
| Trial Design: Randomized clinical trial |
| Population: 828 patients Key inclusion criteria: – Progressive CKD – eGFR between 10.0 and 15.0 ml/min/1.73 m2 of BSA Key exclusion criteria: – eGFR <10.0 ml/min – Plans to receive a kidney transplant from a live donor within 12 months |
| Intervention Studied: Early initiation of dialysis (median time to initiation: 1.80 months) |
| Control: Late initiation of dialysis (Median time to initiation: 7.40 months) |
| Outcomes: – Death: Early-start group: 37.6% vs Late-start group: 36.6% (P=0.75) – Adverse events: No significant difference in the frequency between groups The authors concluded that “In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes.” |
| Citation: Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27. PMID: 20581422. |
CHOIR trial: Epoetin and target hemoglobin for anemia of CKD
| Article Name: Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease |
| URL: https://www.nejm.org/doi/full/10.1056/NEJMoa065485 |
| Journal and year of publication: NEJM, 2006 |
| Trial Design: Randomized clinical trial |
| Population: 1,432 patients Key inclusion criteria: – Adult with CKD and hemoglobin level <11.0 g/dL Key exclusion criteria: – Uncontrolled hypertension – Active GI bleeding – Iron-overload state OR refractory iron-deficiency anemia |
| Intervention Studied: Epoetin Alfa (Target hemoglobin 13.5 g/dL) |
| Control: Epoetin Alfa (Target hemoglobin 11.3 g/dL) |
| Outcomes: – The primary end point was a composite of death, myocardial infarction, hospitalization for congestive heart failure (without renal replacement therapy), and stroke: – High-hemoglobin group: 125 out 715 patient – Low-hemoglobin group:occurred: 97 out of 717 patient – Hazard ratio for high-hemoglobin: 1.34 (95% CI: 1.03 to 1.74) (P=0.03) The authors concluded that “The use of a target hemoglobin level of 13.5 g per deciliter (as compared with 11.3 g per deciliter) was associated with increased risk and no incremental improvement in the quality of life.” |
| Citation: Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98. doi: 10.1056/NEJMoa065485. PMID: 17108343. |
RENAAL trial: Losartan for diabetic nephropathy
| Article Name: Effects of Losartan on Renal and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Nephropathy |
| URL: https://www.nejm.org/doi/full/10.1056/nejmoa011161 |
| Journal and year of publication: NEJM, 2001 |
| Trial Design: Randomized clinical trial |
| Population: 1,513 patients Key inclusion criteria: – Adult with T2DM and nephropathy (Ratio of urinary albumin to creatinine of at least 300 (or a rate of urinary protein excretion of at least 0.5 g/day) and serum creatinine values between 1.3 and 3.0 mg/dL) Key exclusion criteria: – Type 1 DM or nondiabetic renal disease, including renal-artery stenosis |
| Intervention Studied: Losartan (50 to 100 mg once daily) |
| Control: Placebo |
| Outcomes: – Occurrence of primary endpoint (composite of a doubling of the base-line serum creatinine concentration, end-stage renal disease, or death): Losartan group: 327 patients (43.5%) vs Placebo group: 359 patients (47.1%). Risk reduction: 16%, P=0.02 The authors concluded that “Losartan conferred significant renal benefits in patients with type 2 diabetes and nephropathy, and it was generally well tolerated.” |
| Citation: Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar S; RENAAL Study Investigators. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001 Sep 20;345(12):861-9. doi: 10.1056/NEJMoa011161. PMID: 11565518. |
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