Dataset Information

A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185).

ABSTRACT: Background:Hip fracture is a procedure with high mortality and complication rates, and there exists a group especially at risk of these outcomes identified by their Nottingham Hip Fracture Score (NHFS). Meta-analysis suggests a possible benefit to this patient group from intravascular volume optimisation. We investigated whether intraoperative fluid and blood pressure optimisation improved complications in this group. Methods:Patients with a NHFS ??5 were enrolled into this multicentre observer-blinded randomised control trial. Patients were allocated to either standard care or a combination of fluid optimisation and blood pressure control using a non-invasive system. The primary outcome was the number of patients with one or more complications in each group. Secondary outcomes included hospital length of stay (LOS), incidence of hypotension and fluid and vasopressor usage. Results:Forty-six percent of patients in the intervention group suffered one or more complications compared to the 51% in the control group (OR 0.82 (95% CI 0.49-1.36)). Per-protocol analysis improved the OR to 0.73 (95% CI 0.43-1.24). Median LOS was the same between both groups; however, the mean LOS on a per-protocol analysis was longer in the control group compared to the intervention group (23.2 (18.0) days vs. 18.5 (16.5), p?=?0.047). Conclusions:Haemodynamic optimisation including blood pressure management in high-risk patients undergoing repair of a hip fracture did not result in a statistically significant reduction in complications; however, a potential reduction in length of stay was seen. Trial registration:A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185).

SUBMITTER: Davies SJ

PROVIDER: S-EPMC6686254 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185).

Davies S J SJ Yates D R DR Wilson R J T RJT Murphy Z Z Gibson A A Allgar V V Collyer T T

Perioperative medicine (London, England) 20190808

<h4>Background</h4>Hip fracture is a procedure with high mortality and complication rates, and there exists a group especially at risk of these outcomes identified by their Nottingham Hip Fracture Score (NHFS). Meta-analysis suggests a possible benefit to this patient group from intravascular volume optimisation. We investigated whether intraoperative fluid and blood pressure optimisation improved complications in this group.<h4>Methods</h4>Patients with a NHFS ≥ 5 were enrolled into this multic ...[more]

PMID: 31406569

Similar Datasets

Project description:BackgroundAlthough many treatments for ipsilateral proximal and shaft femoral fractures have been developed, controversy exists regarding their optimal management. The purpose of this retrospective study was to discuss the effectiveness of the bridge-link type combined fixation system (BCFS) and evaluate functional outcomes in treating patients with these complex fractures.Patients and methodsWe retrospectively reviewed 14 cases of ipsilateral proximal and shaft femoral fractures treated from January 2012 to December 2016. All cases were treated by BCFS combined with minimally invasive percutaneous plate osteosynthesis (MIPPO). Clinical and radiographic data were collected during regular post-operative follow-up visits. Functional outcomes were determined according to the Friedman and Wyman scoring system.ResultsThe proximal femoral fractures were emergency diagnoses in 11 cases and delayed diagnoses in 3 cases. The delay time was 5-6 days, with an average of 5.3 days. The mean operation time was 179.6 min (range 135-231 min) with a blood loss volume that ranged from 430 to 535 ml (average 483.6 ml). Follow-up was conducted in 13 cases between 9 and 30 months post-operation, with an average follow-up time of 17.3 months. The proximal femoral fractures were united in 12 cases at the final follow-up. One case had nonunion 13 months after the operation, underwent valgus intertrochanteric osteotomy, and healed 6 months later. The femoral shaft fractures obtained rigid union at the latest follow-up in 12 cases. One case endured nonunion 12 months after the operation. After the revision surgery and iliac bone grafting, the fracture healed 6 months later. Eight of the cases had good functional results, 4 had fair results, and results were poor in 1 case at the final follow-up.ConclusionsThe treatment of ipsilateral proximal femoral and shaft fractures with BCFS in combination with MIPPO demonstrated a high likelihood of union for both fractures and good functional results.

Project description:BackgroundA meta-analysis to access the pros and cons of proximal femoral nail anti-rotation (PFNA) versus InterTAN nail for intertrochanteric femoral fractures including available evidence extracted from literature.MethodsAccording to the Cochrane systemic analysis method, randomized control trials (RCTs) and retrospective comparative observational studies which were related to the comparison of PFNA and InterTAN nail in the treatment of the elderly with intertrochanteric fractures were retrieved. Data were independently extracted from the included studies by two reviewers and analyzed using RevMan 5.3, and the quality of the studies was assessed.ResultsTwo RCTs and seven observational studies were recruited, which consisted of 681 patients with PFNA and 651 patients with InterTAN nail. The meta-analyses showed no significant differences between the two approaches on Harris Hip Score, operation time, blood loss, time to union, mean hospital stay, union problems, intraoperative complications, hematoma, infection, and other complications in both RCTs and observational studies. In terms of other outcomes, for the RCTs, results showed that there were shorter tip-apex distance and reduced pain at thigh or hip in InterTAN nail than in PFNA; however, InterTAN nail was not superior to PFNA in cutout, reoperation, and femoral shaft fracture; for observational studies, the risk of the screw migration (RR = 5.13, 95%CI [1.33,19.75], P = 0.02), cutout (RR = 3.26, 95%CI [1.64,6.47], P = 0.0008), the varus collapse of the femoral head (RR = 7.19, 95%CI [2.18,23.76], P = 0.001), femoral shaft fracture (RR = 5.73, 95%CI [2.24,14.65], P = 0.0003) treated by InterTAN nail were significantly decreased, compared with those by PFNA; however, no significant differences were observed in the aspects of tip-apex distance and pain at thigh or hip between these two groups.ConclusionAnalysis of a large number of relevant clinical indicators available shows that InterTAN nail has better clinical manifestation than PFNA in treating unstable femoral intertrochanteric fractures.

Project description:BackgroundThe use of cardiac output monitoring to guide intra-venous fluid and inotropic therapies may improve peri-operative outcomes, but uncertainty exists regarding clinical effectiveness and robust cost-effectiveness evidence is lacking. The objective of the study was to evaluate the cost-effectiveness of peri-operative cardiac output-guided haemodynamic therapy versus usual care in high-risk patients undergoing major gastrointestinal surgery.MethodsThe study undertook a cost-effectiveness analysis using data from a multi-centre randomised trial that recruited patients from 17 hospitals in the United Kingdom. The trial compared cardiac output-guided, haemodynamic therapy algorithm for intra-venous fluid and inotrope (dopexamine) infusion during and 6 h following surgery, with usual care. Resource use and outcome data on 734 high-risk trial patients aged over 50 years undergoing major gastrointestinal surgery were used to report cost-effectiveness at 6 months and to project lifetime cost-effectiveness. The cost-effectiveness analysis used information on health-related quality of life (QoL) at randomisation, 30 days, and 6 months combined with information on vital status to report quality-adjusted life years (QALYs). Each QALY was valued using the National Institute for Health and Care Excellence (NICE) recommended threshold of willingness to pay (£20,000 per QALY) in conjunction with the costs of each group to report the incremental net monetary benefits (INB) of the treatment algorithm versus usual care.ResultsThe mean [SD] quality of life at 30 days and 6 months was similar between the treatment groups (at 6 months, intervention group 0.73 [0.28] versus usual care group 0.71 [0.30]; mean gain 0.03 [95 % confidence interval (CI) -0.01 to 0.08]). At 6 months, survival, mean QALYs and mean healthcare costs (intervention group £8574 versus usual care group £8974) were also similar. At the cost-effectiveness threshold of £20,000 per QALY gained, the incremental net benefit of haemodynamic therapy over the patients' lifetime was positive (£4168 [95 % CI -£3063 to £11,398]). This corresponds to an 87 % probability that this intervention is cost-effective.ConclusionsCardiac output-guided haemodynamic therapy algorithm was associated with an average cost reduction and improvement in QALY and is likely to be cost-effective. Further research is needed to confirm the clinical and cost-effectiveness of this treatment.Trial registrationISRCTN04386758.

Project description:BackgroundThe aim of this meta-analysis was to evaluate the advantages and disadvantages of proximal femoral nail anti-rotation (PFNA) versus dynamic hip screw (DHS) for the treatment of unstable intertrochanteric fractures, including the available evidence drawn from the literature.MethodsA systematic search was conducted to identify available and relevant randomized controlled trials and retrospective comparative observational studies regarding PFNA compared against DHS in treating unstable femoral intertrochanteric fractures in Embase, PubMed, Cochrane Library, Web of Science, and Scopus Online up to February 12, 2022. Data from the included studies were extracted independently by 2 reviewers and analyzed using RevMan 5.3, and the quality of the studies was assessed.ResultsFive randomized controlled trials and 12 observational studies were recruited and met the inclusion criteria, which consisted of 1332 patients with PFNA and 1271 patients with DHS. The results of the meta-analysis showed that, compared with the DHS, PFNA exhibited a beneficial role in postoperative Harris Hip Scores, operation time, intraoperative blood loss, length of hospital stay, fracture healing time and full weight-bearing time, limb shortening, cutout, reoperation, union problems, the varus collapse of the femoral head/neck, and infection; however, DHS was superior to PFNA in hidden blood loss (relative risk [RR] = 139.81, 95% confidence interval [CI] [136.18, 143.43], P < .00001), postoperation drainage (RR = -17.85, 95% CI [-30.10, -5.60], P = .004), total blood loss (RR = 50.34, 95% CI [42.99, 57.69], P < .00001), and femoral shaft fracture (RR = 4.72, 95% CI [1.15, 19.32], P = .03) treated by DHS were significantly decreased, compared with those by PFNA; however, no significant differences were observed in tip-apex distance, fixation failures, screw migration, or other complicants between the 2 surgical methods.ConclusionAnalysis of a large number of relevant clinical indicators available shows that PFNA has better clinical manifestation than DHS in treating unstable femoral intertrochanteric fractures.

Project description:BackgroundPatients with liver cirrhosis undergoing liver transplantation have a hyperdynamic circulation which persists into the early postoperative period making accurate assessment of fluid requirements challenging. Goal-directed fluid therapy (GDFT) has been shown to reduce morbidity and mortality in a number of surgery settings. The impact of GDFT in patients undergoing liver transplantation is unknown. A feasibility trial was designed to determine patient and clinician support for recruitment into a randomised controlled trial of GDFT following liver transplantation, adherence to a GDFT protocol, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate the efficacy of GDFT in patients undergoing liver transplantation.MethodsThe Cardiac output Optimisation following Liver Transplant (COLT) trial is designed as a prospective, single-centre, randomised controlled study to assess the feasibility and safety of GDFT in liver transplantation for patients with cirrhosis. Consenting adults (aged between 18 and 80 years) with biopsy-proven liver cirrhosis who have been selected to undergo a first liver transplantation will be included in the trial and randomised into GDFT or standard care starting immediately after surgery and continuing for the first 12 h thereafter. Both groups will have cardiac output and stroke volume monitored using the FloTrac (EV1000) device. The intervention will consist of a protocolised GDFT approach to patient management, using stroke volume optimisation. The control group will receive standard care, without stroke volume and cardiac output measurement. After 12 h the patient's fluid management will revert to standard of care. The primary endpoint of this study is feasibility. Secondary endpoints will include a safety assessment of the intervention, graft and patient survival, liver function, postoperative complications graded by Clavien-Dindo criteria, length of intensive care and hospital stay and quality of life across the intervention and control groups.DiscussionThere is a growing body of evidence that the use of perioperative GDFT in surgical patients can improve outcomes; however, signals of harm have also been detected. Patients with liver cirrhosis undergoing liver transplantation have markedly different cardiovascular physiology than general surgical patients. If GDFT is proven to be feasible and safe in this patient group, then a multicentre trial to demonstrate efficacy and cost-effectiveness will be required.Trial registrationInternational Standard Randomised Controlled Trial Registry, ID: ISRCTN10329248. Registered on 4 April 2016.

Project description:ObjectivesStudies have demonstrated high rates of mortality in people with proximal femoral fracture and SARS-CoV-2, but there is limited published data on the factors that influence mortality for clinicians to make informed treatment decisions. This study aims to report the 30-day mortality associated with perioperative infection of patients undergoing surgery for proximal femoral fractures and to examine the factors that influence mortality in a multivariate analysis.SettingProspective, international, multicentre, observational cohort study.ParticipantsPatients undergoing any operation for a proximal femoral fracture from 1 February to 30 April 2020 and with perioperative SARS-CoV-2 infection (either 7 days prior or 30-day postoperative).Primary outcome30-day mortality. Multivariate modelling was performed to identify factors associated with 30-day mortality.ResultsThis study reports included 1063 patients from 174 hospitals in 19 countries. Overall 30-day mortality was 29.4% (313/1063). In an adjusted model, 30-day mortality was associated with male gender (OR 2.29, 95% CI 1.68 to 3.13, p<0.001), age >80 years (OR 1.60, 95% CI 1.1 to 2.31, p=0.013), preoperative diagnosis of dementia (OR 1.57, 95% CI 1.15 to 2.16, p=0.005), kidney disease (OR 1.73, 95% CI 1.18 to 2.55, p=0.005) and congestive heart failure (OR 1.62, 95% CI 1.06 to 2.48, p=0.025). Mortality at 30 days was lower in patients with a preoperative diagnosis of SARS-CoV-2 (OR 0.6, 95% CI 0.6 (0.42 to 0.85), p=0.004). There was no difference in mortality in patients with an increase to delay in surgery (p=0.220) or type of anaesthetic given (p=0.787).ConclusionsPatients undergoing surgery for a proximal femoral fracture with a perioperative infection of SARS-CoV-2 have a high rate of mortality. This study would support the need for providing these patients with individualised medical and anaesthetic care, including medical optimisation before theatre. Careful preoperative counselling is needed for those with a proximal femoral fracture and SARS-CoV-2, especially those in the highest risk groups.Trial registration numberNCT04323644.

Dataset Information

A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185).

Publications

A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets