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AbstractObjectiveTo study whether a high volume injection without corticosteroids improves clinical outcome in addition to usual care for adults with chronic midportion Achilles tendinopathy.DesignPatient and assessor blinded, placebo controlled randomised clinical trial.SettingSports medicine department of a large district general hospital, the Netherlands.Participants80 adults (aged 18-70 years) with clinically diagnosed chronic midportion Achilles tendinopathy and neovascularisation on ultrasonography. 39 were randomised to a high volume injection without corticosteroids and 41 to placebo.InterventionsParticipants were instructed to perform an exercise programme for 24 weeks (usual care) combined with one 50 mL high volume injection of saline and lidocaine (intervention group) or one 2 mL placebo injection of saline and lidocaine (placebo group) at baseline.Main outcome measuresPrimary outcome was pain and function assessed using the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire at 24 weeks (analysed using a generalised estimation equations model). Secondary outcomes were patient satisfaction, return to sport, degree of ultrasonographic Doppler flow, visual analogue scale on 10 hop test, power and flexibility of the gastrocnemius and soleus muscles, pain detect questionnaire for neuropathic pain, and pain coping inventory. Participants were evaluated at baseline and at 2, 6, 12, and 24 weeks.ResultsOnly one participant (1%) was lost to follow-up. The estimated mean VISA-A score improved significantly, from 40.4 (95% confidence interval 32.0 to 48.7) at baseline to 59.1 (50.4 to 67.8) at 24 weeks in the high volume injection group and from 36.9 (27.1 to 46.8) to 58.5 (47.9 to 69.1) in the placebo group. The VISA-A score over time did not differ between the groups (adjusted between group difference at 24 weeks 0.5 points, 95% confidence interval −17.8 to 18.8). No significant between group differences were found for patient satisfaction (21/37 (57%) v 19/39 (49%) patients, P=0.50) and return to desired sport (15/29 (52%) v 19/31 (61%) patients active in sports, P=0.65) at 24 weeks. None of the other secondary outcomes differed between the two groups.ConclusionsA high volume injection without corticosteroids in addition to usual care is not effective for symptom reduction in patients with chronic midportion Achilles tendinopathy. On the basis of our findings, we cannot recommend the use of a high volume injection in this patient group.Trial registrationClinicalTrials.gov NCT02996409

Acute pancreatitis (AP) is a common presentation in patients admitted with acute abdomen. Whether Ringers lactate (RL) or Normal Saline (NS) as a resuscitation fluid is better still remains unclear. The aim of this study is to compare the efficacy of RL and NS in terms of control of systemic inflammation by measuring indirect markers specifically Systemic Inflammation Response Syndrome (SIRS) scores and C- Reactive Protein (CRP) level. This was an open label randomized trial conducted in a tertiary level hospital of Nepal. Ethical approval was obtained prior to the study. Patients with acute pancreatitis were randomized to either RL or NS group for the fluid resuscitation. The fluid was given as per the study protocol for three days for hydration. Baseline SIRS and CRP were recorded on admission and subsequently as defined. All the data were analyzed using SPSS ver 20.0 software. Total 51 patients were enrolled, 26 in RL and 25 in NS group. The commonest etiology of AP was alcohol (84.31%). SIRS was present in 46.2% and 64.0% of patients in RL and NS group respectively (p = 0.20) on admission. At least one SIRS criteria was still present in 44.0% of patients in the NS group compared to only 15.4% in the RL group after 24 hours (p = 0.025). The baseline CRP were comparable in both the groups. However after 72 hours, the increment of CRP was more in the NS group compared to the RL group; median value of 14.2 mg/dl (12.15, 16.45) and 22.2 mg/dl (18.20, 30.60) in RL and NS group respectively (p<0.001). Ringers lactate was associated with a reduction in systemic inflammation compared to normal saline in patients with acute pancreatitis. Incidence of SIRS at 72 hours and occurrence of local complications were however similar in both the groups.

In this cluster-randomized, crossover trial, hospital-wide use of lactated Ringer’s solution as compared with normal saline did not alter the incidence of death or hospital readmission within 90 days.

Background Some evidence suggests that fluid resuscitation with lactated Ringer’s solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS) and may be associated with a decrease in severity, but existing single-center randomized controlled trials showed conflicting results. The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP. Methods The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation for at least 48 h. The primary outcome will be moderately severe or severe AP, according to the revision of the Atlanta classification. The secondary objectives of the WATERLAND trial are to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes in patients with AP. A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe or severe AP in the LR group will be 17%. A loss to follow-up of 10% of patients is expected, so the total sample size will be 396 patients in each treatment arm (792 patients overall). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level. Discussion The WATERLAND study aims to improve the early management of AP. Fluid resuscitation is an inexpensive treatment available in any hospital center worldwide. If a better evolution of pancreatitis is demonstrated in one of the treatment arms, it would have important repercussions in the management of this frequent disease. Trial registration ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. EudraCT number 2023–000010-18, first posted March 23, 2023.

Postoperative acute kidney injury (AKI) is common after non-cardiac surgery. Normal saline and lactated Ringer's solution are both used for volume replacement during surgery. Normal saline decreases renal blood flow and causes hyperchloremic acidosis whereas lactated Ringer's does not. The incidence of AKI is similar with modest volumes of each fluid. But it remains unclear whether larger volumes of normal saline provoke AKI. Evaluate whether intraoperative crystalloid volume modifies the relationship between the AKI risk and treatment group. Secondary analysis of a single-center multiple cross-over cluster trial. Intraoperative care. We enrolled 8616 adults who had colorectal or orthopedic surgery at a large academic institution. Clusters of patients were alternately assigned to intraoperative normal saline or lactated Ringer's solution. The primary outcome was the incidence of acute kidney injury (AKI) as a function of intraoperative crystalloid volume (0–1, 1–2, 3–4, or 4+ liters) and the type of crystalloid. Our secondary outcome was the change in postoperative serum chloride concentration during the first 24 h. The risk of AKI did not differ significantly in patients given 0–1, 1–2, or 3–4 L saline or lactated Ringers solutions. In contrast, patients given 2–3 or > 4 L of lactated Ringer's solution had a higher risk of AKI than those given saline. Patients assigned to normal saline had progressively greater plasma chloride concentrations than those given lactated Ringer's across all volume categories. While saline administration clearly causes volume-dependent hyperchloremia, we found no evidence to support the theory that large volumes of saline provoke AKI. Therefore, either fluid seems reasonable for intraoperative use. •The incidence of AKI is similar with modest volumes of normal saline and lactated Ringer's solutions, but it remains unclear whether larger volumes of normal saline provoke AKI.•In a multiple cross-over cluster trial, 8616 patients were assigned to normal saline and lactated Ringer's solutions. Patients given 2–3 or > 4 L of lactated Ringer's solution had a higher risk of AKI than those given saline.•Normal saline and lactated Ringer's solutions both seem reasonable for intraoperative use.

Background Vasospasms are common in patients presenting with non-traumatic subarachnoid haemorrhage (SAH) and are the main contributor to long-term disability or death in these patients. The key immediate management of vasospasms is the improvement of brain perfusion by the administration of intravenous fluid and vasopressors if needed. Yet, there is no clear recommendation regarding the choice of fluid in this particular patient population. Data suggests a survival benefit using normal saline in patients with TBI; however, its impact on outcomes in patients with SAH is lacking. Thus, the aim of this study is to evaluate whether the use of normal saline reduces clinically relevant vasospasms compared to Ringer’s lactate in patients with SAH. Methods Patients presenting with non-traumatic SAH will be randomised 1:1 to normal saline or Ringer’s lactate group. Blinded study fluid will be used exclusively for resuscitation and maintenance until ICU/IMC discharge or a maximum of 14 days, whichever occurs first. Management of vasospasms and general management of the SAH patient will be according to the clinic standard of care. Primary endpoint is the occurrence of clinically relevant vasospasms. Key secondary outcomes include mortality, severity and treatment of vasospasms, and neurological outcomes at 90 days. Discussion The proposed randomised controlled trial offers a safe, non-invasive way to gain insights about crystalloid fluid choice in SAH patients, with potential to improve outcomes in this critically ill patient group. This study could establish a new gold standard in fluid therapy for neuro-critical care. Trial registration The trial is registered on ClinicalTrials.gov (date of registration 18 June 2021) and on the Swiss National Clinical Trials Portal, SNCTP000004575.

ObjectiveTo investigate if treatment with a single injection of autologous micro-fragmented adipose tissue improved patient-reported health compared with a placebo saline injection in patients suffering from pain and functional impairment due to knee osteoarthritis.MethodsWe conducted a randomised controlled trial with patients blinded to the treatment and allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18–70 years with Kellgren-Lawrence grades 2–3 in the tibiofemoral joint and suffering from pain and functional impairment of the knee were eligible for inclusion. Abdominal adipose tissue was harvested by liposuction in all patients. The active treatment group was treated with an intra-articular injection of autologous micro-fragmented adipose tissue, and the placebo group with isotonic saline. The primary outcome was the Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months.Results238 patients were assessed for eligibility and 120 (mean age 52.2, 58% female) included from January 2019 to February 2022. There were no statistically significant differences between the active treatment and the placebo group at any time point. Both groups showed statistically significant and clinically relevant improvements from baseline to 6, 12 and 24 months. Mean KOOS4 at 6 months was 55.5 (95% CI 51.4 to 59.6) for the active treatment group and 51.5 (95% CI 47.4 to 55.6) for the placebo group.ConclusionThis study did not show superiority of micro-fragmented adipose tissue compared with a placebo saline injection for the treatment of knee osteoarthritis.Trial registration number NCT03771989.

Cystic fibrosis (CF) lung disease starts in early infancy, suggesting that preventive treatment may be most beneficial. Lung clearance index (LCI) and chest magnetic resonance imaging (MRI) have emerged as promising endpoints of early CF lung disease; however, randomized controlled trials testing the safety and efficacy of preventive therapies in infants with CF are lacking. To determine the feasibility, safety, and efficacy of preventive inhalation with hypertonic saline (HS) compared with isotonic saline (IS) in infants with CF, including LCI and MRI as outcome measures. In this randomized, double-blind, controlled trial, 42 infants with CF less than 4 months of age were randomized across five sites to twice-daily inhalation of 6% HS (  = 21) or 0.9% IS (  = 21) for 52 weeks. Inhalation of HS and IS was generally well tolerated by infants with CF, and the number of adverse events did not differ between groups (  = 0.49). The change in LCI from baseline to Week 52 was larger in infants with CF treated with HS (-0.6) than in those treated with IS (-0.1;  < 0.05). In addition, weight gain was improved in infants with CF treated with HS (  < 0.05), whereas pulmonary exacerbations and chest MRI scores did not differ in the HS group versus the IS group. Preventive inhalation with HS initiated in the first months of life was safe and well tolerated and resulted in improvements in LCI and weight gain in infants with CF. Our results support the feasibility of LCI as an endpoint in randomized controlled trials in infants with CF. Clinical trial registered with www.clinicaltrials.gov (NCT01619657).

PurposeBolus intravenous administration of 0.9% saline has been associated with the development of pulmonary edema, and increased mortality. An animal model has previously demonstrated that rapid intravenous administration of 0.9% saline was associated with non-hydrostatic lung injury with increased lung lavage protein. We hypothesized that this non-hydrostatic effect would also occur in human volunteers.MethodsIn a randomized, cross-over study of 14 healthy male subjects, the lung lavage protein concentration and cardiorespiratory effects of an intervention with rapid intravenous administration of 30 mL/kg of 0.9% saline were compared with sham intervention. Bronchoalveolar lavage (BAL) was performed after fluid administration. Doppler echocardiography, lung ultrasound, pulmonary function tests, and blood sampling were performed before and after each intervention.ResultsThe BAL total protein concentration was greater after 0.9% saline administration than with sham (196.1 µg/mL (SD 87.6) versus 129.8 µg/mL (SD 55.4), respectively (p = 0.020). Plasma angiopoietin-2 concentration was also increased to 2.26 ng/mL (SD 0.87) after 0.9% saline administration compared with sham 1.53 ng/mL (SD 0.69) (p < 0.001). There were small increases in stroke volume (from 58 mL (IQR 51–74) to 66 mL (IQR 58–74), p = 0.045) and Doppler echocardiography left ventricle E/e’ ratio (from 5.0 (IQR 4.5–6.0) to 5.7 (IQR 5.3–6.3), p = 0.007), but no changes to right ventricular function.ConclusionRapid intravenous administration of 0.9% saline leads to interstitial permeability pulmonary edema in healthy human volunteers. Further research is now warranted to understand these effects in critically ill patients.

Background Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50 °C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure. Methods and materials This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50 °C during surgery. Group B was the control group where room-temperature saline was used. The operative field was assessed using the Boezaart score, duration of surgery, and bleeding in ml. Results The Boezaart score in group A came out to be 2.23 ± 0.72 whereas it was 3.43 ± 0.72 in group B. Most of the patients who were in the interventional group had their surgery completed within 60 min with comparatively less bleeding (mean bleeding = 221.83 ml). Patients of the control group had increased duration of surgery mostly and bleeding (mean = 265.67 ml). Our study showed a strong correlation amongst the Boezaart score, duration of surgery, and bleeding in ml with a p value of < 0.001 where all three variables significantly improved in the interventional group due to a good operative field provided by warm saline heated up to 50 °C. Conclusion Normal saline heated up to 50 °C is a cost-effective way to achieve a bloodless operative field during endoscopic sinus surgery. Reduced bleeding also decreases the duration of surgery.