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Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Endotracheal intubation (ETI) is commonly performed as a life-saving procedure in the intensive care unit (ICU). It is often associated with significant hemodynamic perturbations and can severely impact the outcome of ICU patients. Etomidate is often chosen by many critical care providers for the patients who are hypotensive because of its superior hemodynamic profile compared to other induction medications. However, recent evidence has raised concerns about the increased incidence of adrenal insufficiency and mortality associated with etomidate use. A combination of ketamine and propofol (known as ketofol) has been studied in various settings as an alternative induction agent. In recent years, studies have shown that this combination may provide adequate sedation while maintaining hemodynamic stability, based on the balancing of the hemodynamic effects of these two individual agents. We hypothesized that ketofol may offer a valuable alternative to etomidate in critically ill patients with or without hemodynamic instability. METHODS/DESIGN:A randomized controlled parallel-group clinical trial of adult critically ill patients admitted to either a medical or surgical ICU at Mayo Clinic in Rochester, MN will be conducted. As part of planned emergency research, informed consent will be waived after appropriate community consultation and notification. Patients undergoing urgent or emergent ETI will receive either etomidate or a 1:1 admixture of ketamine and propofol (ketofol). The primary outcome will be hemodynamic instability during the first 15 minutes following drug administration. Secondary outcomes will include ICU length of stay, mortality, adrenal function, ventilator-free days and vasoactive medication use, among others. The planned sample size is 160 total patients. DISCUSSION:The overall goal of this trial is to assess the hemodynamic consequences of a ketamine-propofol combination used in critically ill patients undergoing urgent or emergent ETI compared to etomidate, a medication with an established hemodynamic profile. The trial will address a crucial gap in the literature regarding the optimal induction agent for ETI in patients that may have potential or established hemodynamic instability. Greater experience with planned emergency research will, hopefully, pave the way for future prospective randomized clinical trials in the critically ill population. TRIAL REGISTRATION:Clinicaltrials.gov: NCT02105415. 31 March 2014.

SUBMITTER: Smischney NJ

PROVIDER: S-EPMC4409710 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial.

Smischney Nathan J NJ Hoskote Sumedh S SS Gallo de Moraes Alice A Racedo Africano Carlos J CJ Carrera Perliveh M PM Tedja Rudy R Pannu Jasleen K JK Hassebroek Elizabeth C EC Reddy Dereddi Raja S DR Hinds Richard F RF Thakur Lokendra L

Trials 20150421

<h4>Background</h4>Endotracheal intubation (ETI) is commonly performed as a life-saving procedure in the intensive care unit (ICU). It is often associated with significant hemodynamic perturbations and can severely impact the outcome of ICU patients. Etomidate is often chosen by many critical care providers for the patients who are hypotensive because of its superior hemodynamic profile compared to other induction medications. However, recent evidence has raised concerns about the increased inci ...[more]

PMID: 25909406

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Project description:Propofol, ketamine, and etomidate are common anesthetic agents for induction of anesthesia in the ICU. The choice between these agents is complex and may not depend solely upon severity of illness.ObjectivesTo evaluate the association between the administration of propofol, ketamine, and etomidate and ICU, hospital mortality, and length of stay.Design setting and participantsRetrospective single-center cohort study. ICUs in a tertiary medical center, between January 01, 2012, and December 31, 2017. Critically ill adult patients given a single IV anesthetic for intubation.Main outcome and measuresPrimary outcomes were ICU and hospital mortality. Secondary outcomes were ICU- and hospital-free days through 28 days. An inverse probability of treatment weighed approach was used. The propensity score was estimated using a generalized logit model as a function of patient characteristics, admission source, ICU type, readmission status, length of ICU stays prior to intubation, and acute physiology score. Mortality outcomes were assessed with weighted logistic regression and -free days assessed by weighted linear regression with Bonferroni correction for pairwise comparisons.ResultsOf 2,673 patients, 36% received propofol, 30% ketamine and 34% etomidate. Overall ICU and hospital mortality were 19% and 29%, respectively. Patients given ketamine had higher odds of ICU mortality (1.45; [95% CI, 1.07-1.94]; p = 0.015) and patients given etomidate had higher odds of ICU mortality (1.87; 1.40-2.49; p < 0.001), hospital mortality (1.43; 1.09-1.86; p = 0.009), and less ICU-free days (-2.10; -3.21 to -1.00; p < 0.001) than those given propofol. Patients given ketamine and etomidate had similar odds of hospital mortality (1.06; 0.80-1.42; p = 0.761) and similar hospital-free days (0.30; -0.81 to 1.40; p = 0.600).Conclusions and relevanceCompared with ketamine and etomidate, propofol was associated with better outcome in critically ill patients undergoing anesthesia for intubation. Even after adjusting for severity of illness prior to intubation, residual confounders cannot be excluded.

Project description:BackgroundTracheal intubation is a high-risk intervention commonly performed in critically ill patients. Due to its favorable cardiovascular profile, ketamine is considered less likely to compromise clinical outcomes. This meta-analysis aimed to assess whether ketamine, compared with other agents, reduces mortality in critically ill patients undergoing intubation.MethodsWe searched MEDLINE, Embase, and the Cochrane Library from inception until April 27, 2023, for randomized controlled trials and matched observational studies comparing ketamine with any control in critically ill patients as an induction agent. The primary outcome was mortality at the longest follow-up available, and the secondary outcomes included Sequential Organ Failure Assessment score, ventilator-free days at day 28, vasopressor-free days at day 28, post-induction mean arterial pressure, and successful intubation on the first attempt. For the primary outcome, we used a Bayesian random-effects meta-analysis on the risk ratio (RR) scale with a weakly informative neutral prior corresponding to a mean estimate of no difference with 95% probability; the estimated effect size will fall between a relative risk of 0.25 and 4. The RR and 95% credible interval (CrI) were used to estimate the probability of mortality reduction (RR < 1). The secondary outcomes were assessed with a frequentist random-effects model. We registered this study in Open Science Framework ( https://osf.io/2vf79/ ).ResultsWe included seven randomized trials and one propensity-matched study totaling 2978 patients. Etomidate was the comparator in all the identified studies. The probability that ketamine reduced mortality was 83.2% (376/1475 [25%] vs. 411/1503 [27%]; RR, 0.93; 95% CrI, 0.79-1.08), which was confirmed by a subgroup analysis excluding studies with a high risk of bias. No significant difference was observed in any secondary outcomes.ConclusionsAll of the included studies evaluated ketamine versus etomidate among critically ill adults requiring tracheal intubation. This meta-analysis showed a moderate probability that induction with ketamine is associated with a reduced risk of mortality.

Dataset Information

Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial.

Publications

Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial.

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