Dataset Information

Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial.

ABSTRACT:

Background

One of the most dreaded complications of septic shock is acute kidney injury. It occurs in around 50% of patients, with a mortality rate of about 60% at 3 months. There is no consensus on the optimal time to initiate renal replacement therapy. Retrospective and observational studies suggest that early implementation of renal replacement therapy could improve the prognosis for these patients.

Methods/design

This protocol summarizes the rationale and design of a randomized, controlled, multicenter trial investigating the effect of early versus delayed renal replacement therapy in patients with severe acute kidney injury in early septic shock. In total, 864 critically ill adults with septic shock and evidence of acute kidney injury, defined as the failure stage of the RIFLE classification, will be enrolled. The primary outcome is mortality at 90 days. Secondary outcomes include safety, number of days free of mechanical ventilation, number of days free of renal replacement therapy, intensive care length of stay, in-hospital length of stay, quality of life as evaluated by the EQ-5D and renal replacement therapy dependence at hospital discharge. The primary analysis will be intention to treat. Recruitment started in March 2012 and will be completed by March 2015.

Discussion

This protocol for a randomized controlled study investigating the impact of the timing of renal replacement therapy initiation should provide an answer to a key question for the management of patients with acute kidney injury in the context of septic shock, for whom the mortality rate remains close to 60% despite improved understanding of physiopathology and recent therapeutic advances.

Trial registration

ClinicalTrials.gov identifier NCT01682590, registered on 10 September 2012.

SUBMITTER: Barbar SD

PROVIDER: S-EPMC4226975 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial.

Barbar Saber Davide SD Binquet Christine C Monchi Mehran M Bruyère Rémi R Quenot Jean-Pierre JP

Trials 20140707

<h4>Background</h4>One of the most dreaded complications of septic shock is acute kidney injury. It occurs in around 50% of patients, with a mortality rate of about 60% at 3 months. There is no consensus on the optimal time to initiate renal replacement therapy. Retrospective and observational studies suggest that early implementation of renal replacement therapy could improve the prognosis for these patients.<h4>Methods/design</h4>This protocol summarizes the rationale and design of a randomize ...[more]

PMID: 24998258

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Project description:IntroductionInitiating dialysis in acute kidney injury (AKI) in an intensive care unit (ICU) remains a subjective clinical decision. We examined factors and practice patterns that influence early initiation of dialysis in ICU patients with acute kidney injury.MethodsAn online survey presented nephrologists (international) with three case scenarios with unstated predicted mortality rates of < 10%, 10 - 30% and > 30%. For each case the respondents were asked 4 questions about influences on the decision whether or not to initiate dialysis within 24 hours: Q1, likelihood of initiating dialysis; Q2, threshold of BUN levels (< 50, 50 - 75, 76 - 100, > 100 mg/dl) considered relevant to this decision; Q3, magnitude of creatinine elevation (two to three-fold increase; greater than threefold increase; absolute level > 5 mg/dl regardless of change) considered relevant; Q4, a rank order of the influence of five parameters (BUN level, change of creatinine from baseline, oxygen saturation, potassium level, and urine output), 1 being the most influential and 5 being the least influential.ResultsOne hundred seventy-two nephrologists (73% in practice for > 5 years; 70% from the U.S.A.) responded to the survey. The proportion of subjects likely to initiate early dialysis increased (76% to 94%), as did the predicted mortality (p < 0.001). The proportion of subjects considering early dialysis at a BUN level ≤ 75 increased from 17% to 30 to 40% as the predicted mortality of the cases increased (p < 0.0001). The proportion of subjects choosing absolute creatinine level to be more influential than relative increment, went from 60% to 54% to 43% as predicted mortality increased (p < 0.0001). Rank-order analysis indicated that influence of oxygen saturation and potassium level on dialysis decision showed a significant change with severity of illness, but BUN level and creatinine elevation remained less influential, and did not change with severity.ConclusionsSeverely ill patients were more likely to be subjected to early dialysis initiation, but its utility is not clear. Rank-order analysis indicates dialysis initiation is still influenced by "imminent" indications rather than a "proactive" decision based on the severity of AKI or azotemia.

Project description:IntroductionDespite recent advances in the management of septic shock, mortality remains unacceptably high. Earlier initiation of key therapies including appropriate antimicrobials and fluid resuscitation appears to reduce the mortality in this condition. This study examined whether early initiation of vasopressor therapy is associated with improved survival in fluid therapy-refractory septic shock.MethodsUtilizing a well-established database, relevant information including duration of time to vasopressor administration following the initial documentation of recurrent/persistent hypotension associated with septic shock was assessed in 8,670 adult patients from 28 ICUs in Canada, the United States of America, and Saudi Arabia. The primary endpoint was survival to hospital discharge. Secondary endpoints were length of ICU and hospital stay as well as duration of ventilator support and vasopressor dependence. Analysis involved multivariate linear and logistic regression analysis.ResultsIn total, 8,640 patients met the definition of septic shock with time of vasopressor/inotropic initiation documented. Of these, 6,514 were suitable for analysis. The overall unadjusted hospital mortality rate was 53%. Independent mortality correlates included liver failure (odds ratio (OR) 3.46, 95% confidence interval (CI), 2.67 to 4.48), metastatic cancer (OR 1.63, CI, 1.32 to 2.01), AIDS (OR 1.91, CI, 1.29 to 2.49), hematologic malignancy (OR 1.88, CI, 1.46 to 2.41), neutropenia (OR 1.78, CI, 1.27 to 2.49) and chronic hypertension (OR 0.62 CI, 0.52 to 0.73). Delay of initiation of appropriate antimicrobial therapy (OR 1.07/hr, CI, 1.06 to 1.08), age (OR 1.03/yr, CI, 1.02 to 1.03), and Acute Physiology and Chronic Health Evaluation (APACHE) II Score (OR 1.11/point, CI, 1.10 to 1.12) were also found to be significant independent correlates of mortality. After adjustment, only a weak correlation between vasopressor delay and hospital mortality was found (adjusted OR 1.02/hr, 95% CI 1.01 to 1.03, P <0.001). This weak effect was entirely driven by the group of patients with the longest delays (>14.1 hours). There was no significant relationship of vasopressor initiation delay to duration of vasopressor therapy (P?=?0.313) and only a trend to longer duration of ventilator support (P?=?0.055) among survivors.ConclusionMarked delays in initiation of vasopressor/inotropic therapy are associated with a small increase in mortality risk in patients with septic shock.

Project description:BackgroundThe effect of the timing of norepinephrine initiation on clinical outcomes in patients with septic shock is uncertain. A systematic review and meta-analysis was performed to evaluate the impact of early and late start of norepinephrine support on clinical outcomes in patients with septic shock.MethodsWe searched the PubMed, Cochrane, and Embase databases for randomized controlled trials (RCTs) and cohort studies from inception to the 1st of March 2020. We included studies involving adult patients (> 18 years) with septic shock. All authors reported our primary outcome of short-term mortality and clearly comparing early versus late norepinephrine initiation with clinically relevant secondary outcomes (ICU length of stay, time to achieved target mean arterial pressure (≥ 65 mmHg), and volume of intravenous fluids within 6 h). Results were expressed as odds ratio (OR) and mean difference (MD) with accompanying 95% confidence interval (CI).ResultsFive studies including 929 patients were included. The primary outcome of this meta-analysis showed that the short-term mortality of the early group was lower than that of the late group (odds ratio [OR] = 0.45; 95% CI, 0.34 to 0.61; P < 0.00001; χ2 = 3.74; I2 = 0%). Secondary outcomes demonstrated that the time to achieved target MAP of the early group was shorter than that of the late group (mean difference = - 1.39; 95% CI, - 1.81 to - 0.96; P < 0.00001; χ2 = 1.03; I2 = 0%). The volume of intravenous fluids within 6 h of the early group was less than that of the late group (mean difference = - 0.50; 95% CI, - 0.68 to - 0.32; P < 0.00001; χ2 = 33.76; I2 = 94%). There was no statistically significant difference in the ICU length of stay between the two groups (mean difference = - 0.11; 95% CI, - 1.27 to 1.05; P = 0.86; χ2 = 0.85; I2 = 0%).ConclusionsEarly initiation of norepinephrine in patients with septic shock was associated with decreased short-term mortality, shorter time to achieved target MAP, and less volume of intravenous fluids within 6 h. There was no significant difference in ICU length of stay between early and late groups. Further large-scale RCTs are still required to confirm these results.

Project description:BackgroundPhysicians' perceptions and opinions may influence when to initiate dialysis.ObjectiveTo examine providers' perspectives and opinions regarding the timing of dialysis initiation.DesignOnline survey.SettingCommunity and academic dialysis practices in Canada.ParticipantsA nationally-representative sample of dialysis providers.Measurements and methodsDialysis providers opinions assessing reasons to initiate dialysis at low or high eGFR. Responses were obtained using a 9-point Likert scale. Early dialysis was defined as initiation of dialysis in an individual with an eGFR greater than or equal to 10.5 ml/min/m(2). A detailed survey was emailed to all members of the Canadian Society of Nephrology (CSN) in February 2013. The survey was designed and pre-tested to evaluate duration and ease of administration.ResultsOne hundred and forty one (25% response rate) physicians participated in the survey. The majority were from urban, academic centres and practiced in regionally administered renal programs. Very few respondents had a formal policy regarding the timing of dialysis initiation or formally reviewed new dialysis starts (N = 4, 3.1%). The majority of respondents were either neutral or disagreed that late compared to early dialysis initiation improved outcomes (85-88%), had a negative impact on quality of life (89%), worsened AVF or PD use (84-90%), led to sicker patients (83%) or was cost effective (61%). Fifty-seven percent of respondents felt uremic symptoms occurred earlier in patients with advancing age or co-morbid illness. Half (51.8%) of the respondents felt there was an absolute eGFR at which they would initiate dialysis in an asymptomatic patient. The majority of respondents would initiate dialysis for classic indications for dialysis, such as volume overload (90.1%) and cachexia (83.7%) however a significant number chose other factors that may lead them to early dialysis initiation including avoiding an emergency (28.4%), patient preference (21.3%) and non-compliance (8.5%).Limitations25% response rate.ConclusionsAlthough the majority of nephrologists in Canada who responded followed evidence-based practice regarding the timing of dialysis initiation, knowledge gaps and areas of clinical uncertainty exist. The implementation and evaluation of formal policies and knowledge translation activities may limit potentially unnecessary early dialysis initiation.

Dataset Information

Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial.

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