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Lung Ultrasound-Guided Fluid Management versus Standard Care in Surgical ICU Patients: A Randomised Controlled Trial.

ABSTRACT: The value of lung ultrasound (LU) in assessing extravascular lung water (EVLW) was demonstrated by comparing LU with gold-standard methods for EVLW assessment. However, few studies have analysed the value of B-Line score (BLS) in guiding fluid management during critical illness. The purpose of this trial was to evaluate if a BLS-guided fluid management strategy could improve fluid balance and short-term mortality in surgical intensive care unit (ICU) patients. We conducted a randomised, controlled trial within the ICUs of two university hospitals. Critically ill patients were randomised upon ICU admission in a 1:1 ratio to BLS-guided fluid management (active group) or standard care (control group). In the active group, BLS was monitored daily until ICU discharge or day 28 (whichever came first). On the basis of BLS, different targets for daily fluid balance were set with the aim of avoiding or correcting moderate/severe EVLW increase. The primary outcome was 28-day mortality. Over 24 months, 166 ICU patients were enrolled in the trial and included in the final analysis. Trial results showed that daily BLS monitoring did not lead to a different cumulative fluid balance in surgical ICU patients as compared to standard care. Consecutively, no difference in 28-day mortality between groups was found (10.5% vs. 15.6%, p = 0.34). However, at least 400 patients would have been necessary for conclusive results.

SUBMITTER: Rusu DM

PROVIDER: S-EPMC8394150 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Lung Ultrasound-Guided Fluid Management versus Standard Care in Surgical ICU Patients: A Randomised Controlled Trial.

Rusu Daniel-Mihai DM Grigoraș Ioana I Blaj Mihaela M Siriopol Ianis I Ciumanghel Adi-Ionut AI Sandu Gigel G Onofriescu Mihai M Lungu Olguta O Covic Adrian Constantin AC

Diagnostics (Basel, Switzerland) 20210810 8

The value of lung ultrasound (LU) in assessing extravascular lung water (EVLW) was demonstrated by comparing LU with gold-standard methods for EVLW assessment. However, few studies have analysed the value of B-Line score (BLS) in guiding fluid management during critical illness. The purpose of this trial was to evaluate if a BLS-guided fluid management strategy could improve fluid balance and short-term mortality in surgical intensive care unit (ICU) patients. We conducted a randomised, controll ...[more]

PMID: 34441378

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Project description:BackgroundDespite the evidence for calibrated cardiac monitored devices to determine fluid responsiveness, there is minimal evidence that the use of cardiac output monitor devices leads to an overall change in IV fluid use. We sought to investigate the feasibility of performing a randomised controlled study using calibrated cardiac output monitoring devices in shocked ICU patients and whether the use of these devices led to a difference in total volume of IV fluid administered.MethodsWe performed a single-centre non-blinded randomised controlled study which included patients who met the clinical criteria for shock on admission to ICU. Patients were divided into two groups (cardiac output monitors or standard) by block randomisation. Patients allocated to the cardiac output monitor all received EV1000 with Volume View sets. Daily intravenous fluid administration and cumulative fluid balance was recorded for 3 days. The primary outcome assessed was the difference in daily intravenous fluid administration and cumulative fluid balance at 72 h between the two groups. We also assessed how often the clinicians used the cardiac monitor to guide fluid therapy and the different reasoning for initiating further intravenous fluids.ResultsEighty patients were randomised and 37 received calibrated cardiac output monitors. We found no adverse outcomes in the use of calibrated cardiac output monitoring devices and that was feasible to perform a randomised controlled trial. There was no significant difference between the standard care group vs the cardiac monitoring group for cumulative fluid balance (2503 ± 3764 ml vs 2458 ± 3560 ml, p = 0.96). There was no significant difference between the groups for daily intravenous fluid administration on days 1, 2 or 3. In the cardiac monitored group, only 43% of the time was the EV1000 output incorporated into the decision to give further intravenous fluids.ConclusionIt is feasible to perform a randomised controlled trial using calibrated cardiac output monitoring devices. In addition, there was no trend to suggest that the use of a cardiac monitors leads to lower IV fluid use in the shocked patient. Further trials will require study designs to optimise the use of a cardiac output monitor to determine the utility of these devices in the shocked patient.Trial registrationANZCTR, ACTRN12618001373268. Registered 15 August 2018-retrospectively registered.

Project description:BackgroundThe aim of this study was to compare the efficacy of ultrasound guided aspiration of hydrosalpinx fluid at the time of oocyte retrieval with salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET.MethodsOne hundred and sixty patients with ultrasound visible hydrosalpinx were randomized into salpingectomy group and aspiration group using computer generated randomization list and sequentially numbered sealed envelopes containing allocation information written on a card.ResultsThe clinical pregnancy rate per started cycle and the implantation rate were non- significantly higher in the salpingectomy group compared with the aspiration group [40% vs. 27.5% (p value = 0.132) and 18.95% vs. 12.82% (p value =0.124), respectively]. In the aspiration group, 34.21% of patients had rapid re-accumulation of the hydrosalpinx fluid (i.e. within first two weeks after embryo transfer). Whereas, the clinical pregnancy rate per transfer cycle and the implantation rate were significantly higher in salpingectomy group compared with the subgroup of patients with rapid re-accumulation of hydrosalpinx fluid [42.67% vs. 19.23% (p value = 0.036) and 18.95% vs. 7.58% (p value = 0.032), respectively], no significant differences were detected between the salpingectomy group and the subgroup of patients with no re-accumulation of hydrosalpinx fluid (42.67% vs. 34% (p value = 0.356) and 18.95% vs. 15.5% (p value = 0.457), respectively).ConclusionThe small sample size could be the cause of failure of detecting significant increase in implantation and pregnancy rates in salpingectomy group compared with aspiration group. Further larger randomized controlled trials are needed to determine whether salpingectomy is more effective than aspiration of hydrosalpinx fluid or not. Moreover, the data presented in this study suggested that rapid re-accumulation of hydrosalpinx fluid is an obstacle against successful implantation and the cause of lower success rate with ultrasound guided aspiration of hydrosalpinx fluid compared with salpingectomy.Trial registrationClinical trials.gov ( NCT02008240 ), registered 8 December 2013.

Project description:IntroductionIntravenous fluid therapy is the most common intervention in critically ill children. There is an increasing body of evidence questioning the safety of high-volume intravenous fluid administration in these patients. To date, the optimal fluid management strategy remains unclear. We aimed to test the feasibility of a pragmatic randomised controlled trial comparing a restrictive with a standard (liberal) fluid management strategy in critically ill children.Methods and analysisMulticentre, binational pilot, randomised, controlled, open-label, pragmatic trial. Patients <18 years admitted to paediatric intensive care unit and mechanically ventilated at the time of screening are eligible. Patients with tumour lysis syndrome, diabetic ketoacidosis or postorgan transplant are excluded.Interventions1:1 random assignment of 154 individual patients into two groups-restrictive versus standard, liberal, fluid strategy-stratified by primary diagnosis (cardiac/non-cardiac). The intervention consists of a restrictive fluid bundle, including lower maintenance fluid allowance, limiting fluid boluses, reducing volumes of drug delivery and initiating diuretics or peritoneal dialysis earlier. The intervention is applied for 48 hours postrandomisation or until discharge (whichever is earlier).EndpointsThe number of patients recruited per month and proportion of recruited to eligible patients are feasibility endpoints. New-onset acute kidney injury and the incidence of clinically relevant central venous thrombosis are safety endpoints. Fluid balance at 48 hours after randomisation is the efficacy endpoint. Survival free of paediatric intensive care censored at 28 days is the clinical endpoint.Ethics and disseminationEthics approval was gained from the Children's Health Queensland Human Research Ethics Committee (HREC/21/QCHQ/77514, date: 1 September 2021), and University of Zurich (2021-02447, date: 17 March 2023). The trial is registered with the Australia New Zealand Clinical Trials Registry (ACTRN12621001311842). Open-access publication in high impact peer-reviewed journals will be sought. Modern information dissemination strategies will also be used including social media to disseminate the outcomes of the study.Trial registration numberACTRN12621001311842.Protocol version/dateV5/23 May 2023.

Project description:BackgroundFluid therapy is a common intervention in critically ill patients. It is increasingly recognised that deresuscitation is an essential part of fluid therapy and delayed deresuscitation is associated with longer invasive ventilation and length of intensive care unit (ICU) stay. However, optimal timing and rate of deresuscitation remain unclear. Lung ultrasound (LUS) may be used to identify fluid overload. We hypothesise that daily LUS-guided deresuscitation is superior to deresuscitation without LUS in critically ill patients expected to undergo invasive ventilation for more than 24 h in terms of ventilator free-days and being alive at day 28.MethodsThe "effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients" (CONFIDENCE) is a national, multicentre, open-label, randomised controlled trial (RCT) in adult critically ill patients that are expected to be invasively ventilated for at least 24 h. Patients with conditions that preclude a negative fluid balance or LUS examination are excluded. CONFIDENCE will operate in 10 ICUs in the Netherlands and enrol 1000 patients. After hemodynamic stabilisation, patients assigned to the intervention will receive daily LUS with fluid balance recommendations. Subjects in the control arm are deresuscitated at the physician's discretion without the use of LUS. The primary endpoint is the number of ventilator-free days and being alive at day 28. Secondary endpoints include the duration of invasive ventilation; 28-day mortality; 90-day mortality; ICU, in hospital and total length of stay; cumulative fluid balance on days 1-7 after randomisation and on days 1-7 after start of LUS examination; mean serum lactate on days 1-7; the incidence of reintubations, chest drain placement, atrial fibrillation, kidney injury (KDIGO stadium ≥ 2) and hypernatremia; the use of invasive hemodynamic monitoring, and chest-X-ray; and quality of life at day 28.DiscussionThe CONFIDENCE trial is the first RCT comparing the effect of LUS-guided deresuscitation to routine care in invasively ventilated ICU patients. If proven effective, LUS-guided deresuscitation could improve outcomes in some of the most vulnerable and resource-intensive patients in a manner that is non-invasive, easy to perform, and well-implementable.Trial registrationClinicalTrials.gov NCT05188092. Registered since January 12, 2022.

Project description:BackgroundThough ultrasound-guided percutaneous lung needle biopsy (US-PLNB) is a first-line small biopsy method for peripheral lung lesions, quality of cellularity in specimens obtained via US-PLNB is uncertain. This study investigated the accuracy, sensitivity, and cellularity of US-PLNB. It examined the ability of contrast-enhanced ultrasound (CEUS) to improve the effectiveness of US-PLNB.MethodsWe retrospectively analyzed all data of patients with subpleural lung lesions who underwent US-PLNB. The cellularity of US-PLNB from malignant lesions included the tumor cell number and proportion. The definition of high-quality cellularity (HQC) was concurrently achieving a tumor cell number ≥400 and a proportion ≥20%. The sensitivity, the actual numbers of tumor cell number/proportion, and the rate of HQC were calculated and compared between the CEUS and non-enhanced US groups after propensity score matching (PSM) with subgroup analyses by lesion size (small lesion ≤30 mm and large lesion >30 mm).ResultsA total of 345 patients undergoing 345 US-PLNBs were evaluated, with 3.7±1.1 of punctures on average. There were 201 malignant and 144 benign lesions with a mean size of 43.8±24.1 mm. Among the 201 malignant lesions, 124 cases underwent CEUS and 77 underwent non-enhanced US. The quantity of tumor cells, the proportion of tumor cells, and the rate of HQC in 201 cases of US-PLNB from malignant lesions were 2,862.1±2,288.0, 44.6%±24.5%, and 82.1% [95% confidence interval (CI): 76.6% to 87.1%], respectively. The quantity of tumor cells, the proportion of tumor cells, and rate of HQC were significantly higher in the CEUS group than that in the non-enhanced US group, both in the analysis of overall malignant lesions and in large malignant lesions (all P<0.05).ConclusionsThe US-PLNB has high sensitivity and thereby obtains HQC samples for subpleural lung malignant lesions. The CEUS helps improve the rate of HQC and tissue cellularity of lung malignancies.

Dataset Information

Lung Ultrasound-Guided Fluid Management versus Standard Care in Surgical ICU Patients: A Randomised Controlled Trial.

Publications

Lung Ultrasound-Guided Fluid Management versus Standard Care in Surgical ICU Patients: A Randomised Controlled Trial.

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