Immune enhancement to prevent infected pancreatic necrosis: A double-blind randomized controlled trial

BACKGROUND&AIMS Infected pancreatic necrosis (IPN) is a highly morbid complication of acute pancreatitis(AP). Since there is evidence of immunosuppression in the early phase of AP, immune enhancement using Thymosin alpha 1 (Tα1), which stimulates both innate and adaptive immunity, may be a therapeutic strategy to prevent IPN. Our aim was to assess the efficacy of early Tα1 treatment on the development of IPN. METHODS We conducted a multicenter, randomized, double-blind, placebo-controlled trial in patients with predicted severe acute necrotizing pancreatitis (ANP). ANP patients with an APACHE II score≥8 admitted within seven days of the advent of symptoms were considered eligible. Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg, every 12 hours for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebo (normal saline). The primary outcome was the development of IPN during the index admission. RESULTS From Mar 2017 through Dec 2020, 508 patients were randomized at 16 hospitals, of whom 254 were assigned to receive Tα1 and 254 placebo. During the index admission, 40/254 (15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95%CI -7.4% to 5.0%]; p=0.47). The results were similar in four predefined subgroups. There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15.0%; p=0.15), bleeding (6.3% vs. 3.5%; p=0.15), and gastrointestinal fistula (2.0% vs. 2.4%; p=0.75) during the index admission. CONCLUSIONS The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.

Download Full-text

Infected Pancreatic Necrosis Mimicking Pancreatic Cancer

Case Reports in Gastroenterology ◽

10.1159/000510161 ◽

2020 ◽

Vol 14 (2) ◽

pp. 436-442

Author(s):

Jun Heo

Keyword(s):

Pancreatic Cancer ◽

Abdominal Pain ◽

Endoscopic Ultrasound ◽

Fine Needle Aspiration ◽

Pancreatic Necrosis ◽

Necrotizing Pancreatitis ◽

Needle Aspiration ◽

Infected Pancreatic Necrosis ◽

Ultrasound Guided ◽

Fine Needle

Although infected pancreatic necrosis can develop as a result of rare conditions involving trauma, surgery, and systemic infection with an uncommon pathogen, it usually occurs as a complication of pancreatitis. Early phase of acute pancreatitis can be either edematous interstitial pancreatitis or necrotizing pancreatitis. The late complications of pancreatitis can be divided into pancreatic pseudocyst due to edematous interstitial pancreatitis or walled-off necrosis due to necrotizing pancreatitis. During any time course of pancreatitis, bacteremia can provoke infection inside or outside the pancreas. The patients with infected pancreatic necrosis may have fever, chills, and abdominal pain as inflammatory symptoms. These specific clinical presentations can differentiate infected pancreatic necrosis from other pancreatic diseases. Herein, I report an atypical case of infected pancreatic necrosis in which abdominal pain, elevation of white blood cell, and fever were not found at the time of admission. Rather, a 10-kg weight loss (from 81 to 71 kg) over 2 months nearly led to a misdiagnosis of pancreatic cancer. The patient was finally diagnosed based on endoscopic ultrasound-guided fine-needle aspiration. This case highlights that awareness of the natural course of pancreatitis and infected pancreatic necrosis is important. In addition, endoscopic ultrasound-guided fine-needle aspiration should be recommended for the diagnosis and treatment of indeterminate pancreatic lesions in selected patients.

Download Full-text

Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

Karger Kompass Pneumologie ◽

10.1159/000513487 ◽

2020 ◽

pp. 1-3

Author(s):

Maximilian Jorczyk

Keyword(s):

Very Low Birth Weight ◽

Controlled Trial ◽

Preterm Neonates ◽

Double Blind ◽

Mechanically Ventilated ◽

Before And After ◽

Anti Inflammatory ◽

To Receive ◽

Therapeutic Possibilities ◽

Inflammatory Effect

Introduction: Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. Objective: The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. Methods: This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for Ureaplasma. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). Results: Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood. Conclusions: Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O2 dependency at 28 days/death in mechanically ventilated preterm neonates.

Download Full-text

Efficacy of Oral Acetaminophen and Intravenous Chlorpheniramine Maleate versus Placebo to Prevent Red Cell Transfusion Reactions in Children and Adolescent with Thalassemia: A Prospective, Randomized, Double-Blind Controlled Trial

Anemia ◽

10.1155/2018/9492303 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Piya Rujkijyanont ◽

Chalinee Monsereenusorn ◽

Pimpat Manoonphol ◽

Chanchai Traivaree

Keyword(s):

Blood Transfusion ◽

Controlled Trial ◽

Febrile Reaction ◽

Chlorpheniramine Maleate ◽

Clinical Trial Registry ◽

Double Blind ◽

Urticarial Rash ◽

To Receive ◽

Transfusion Reactions ◽

Rbc Transfusion

Background. Thalassemia is a common congenital hemolytic disorder. In severe cases, regular blood transfusion is essentially required. The role of premedications to prevent transfusion reactions is varied among institutions with no standard guideline. Objective. To prospectively compare the risk of transfusion reactions in thalassemia patients premedicated with acetaminophen and chlorpheniramine maleate (CPM) versus placebo prior to blood transfusion. Material and Method. A randomized, double-blinded, placebo-controlled transfusion reaction study of 147 eligible patients was analyzed. All administered red blood cell (RBC) products were leukoreduced blood products. Patients were monitored and followed for the development of transfusion reactions for 24 hours after RBC transfusion. Results. A total of 73 patients randomized to receive active drugs consisting of acetaminophen and CPM were compared to 74 patients receiving placebo. The overall incidences of febrile reaction and urticarial rash were 6.9% and 22% in the patients randomized to receive active drugs comparing with 9.5% and 35.2% in the patients receiving placebo with no significant differences between two groups. However, delayed development of urticarial rash at 4-24 hours after RBC transfusion was significantly higher in female and patients receiving placebo. Conclusion. Administration of premedications in thalassemia patients receiving RBC transfusion without a history of transfusion reactions does not decrease the overall risk of transfusion reactions. However, the use of CPM might be beneficial to prevent delayed urticarial rash in those patients especially in females (Thai Clinical Trial Registry (TCTR) study ID: 20140526001).

Download Full-text

Effect of oral sugar solution for reducing pain in infants underwent diphtheria, pertussis, tetanus (DPT) im- munization: a randomized, double-blind controlled trial

Paediatrica Indonesiana ◽

10.14238/pi48.1.2008.23-7 ◽

2008 ◽

Vol 48 (1) ◽

pp. 23 ◽

Cited By ~ 2

Author(s):

Arief Priambodo ◽

Madarina Julia ◽

Djauhar Ismail

Keyword(s):

Median Duration ◽

Controlled Trial ◽

Intervention Group ◽

Oral Solution ◽

Health Centers ◽

Sugar Solution ◽

Negative Effects ◽

Double Blind ◽

Primary Health ◽

To Receive

Background Infants are often subjected to painful procedures suchas diphtheria, pertussis, tetanus (DTP) immunization. Despiteits negative effects, pain in infants has not got enough attention.Sweet oral solution has analgesic effect.Objective To determine whether oral sugar solution can reducethe duration of crying in infants who got DTP immunization.Methods This was a randomized, double-blind controlled trialperformed at Growth and Development Clinic of Dr. SardjitoGeneral Hospital and two Primary Health Centers in Yogyakarta.Study subjects were 4-6 month-old infants who got the 3 rd DTPimmunization. Subjects were randomly allocated to receive 2 ml75% oral sugar solution (intervention group) or 2 ml drinkingwater (placebo) just before the immunization. Crying was recordedfrom just before the injection until 3 minutes after.Results Eighty-six subjects were enrolled; 42 subjects receivedsugar solution and 44 subjects received placebo. Sugar solutionreduced the median duration of first cry about 38 seconds or 32%(P=0.03) and reduced the median duration of total crying about35 seconds or 24% (P=0.02).Conclusion Administration of 2 ml 75% oral sugar solution canalleviate pain associated with DTP immunization as shown byreduced duration of crying.

Download Full-text

A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

Journal of Neurosurgery ◽

10.3171/jns.1988.69.5.0687 ◽

1988 ◽

Vol 69 (5) ◽

pp. 687-691 ◽

Cited By ~ 73

Author(s):

Ross Bullock ◽

James R. van Dellen ◽

William Ketelbey ◽

S. Gustav Reinach

Keyword(s):

Controlled Trial ◽

Prophylactic Antibiotics ◽

Risk Of Infection ◽

Broad Spectrum Antibiotic ◽

Wound Sepsis ◽

Double Blind ◽

Content Type ◽

Exact Test ◽

Significant Difference ◽

To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

Download Full-text

Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

10.1101/2021.04.13.21255409 ◽

2021 ◽

Author(s):

Juan Manuel Figueroa ◽

Monica Lombardo ◽

Ariel Dogliotti ◽

Luis Flynn ◽

Robert P. Giugliano ◽

...

Keyword(s):

Placebo Group ◽

Nasal Spray ◽

Controlled Trial ◽

Hospital Personnel ◽

Culture Methods ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Efficacy ◽

To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

Download Full-text

Comparative Effectiveness of Amoxicillin and Amoxicillin-Clavulanate Potassium in Acute Paranasal Sinus Infections in Children: A Double-Blind, Placebo-Controlled Trial

PEDIATRICS ◽

10.1542/peds.77.6.795 ◽

1986 ◽

Vol 77 (6) ◽

pp. 795-800 ◽

Cited By ~ 3

Author(s):

Ellen R. Wald ◽

Darleen Chiponis ◽

Jocyline Ledesma-Medina

Keyword(s):

Group A Streptococcus ◽

Maxillary Sinusitis ◽

Controlled Trial ◽

Relative Effectiveness ◽

Nasal Discharge ◽

Cure Rate ◽

Double Blind ◽

Amoxicillin Clavulanate ◽

Group A ◽

To Receive

This study compared the relative effectiveness of two antimicrobial preparations, amoxicillin and amoxicillin-clavulanate potassium (Augmentin), in the treatment of acute maxillary sinusitis in children 2 to 16 years of age. Of 171 children with persistent (ten to 30 days' duration) nasal discharge or daytime cough or both, 136 (80%) had abnormal maxillary sinus radiographs. These children were stratified by age and severity of symptoms and randomly assigned to receive either amoxicillin, amoxicillin-clavulanate potassium, or placebo. After the exclusion of 28 children with throat cultures positive for group A Streptococcus and 15 who did not complete their medication, the remaining 93 children were evaluated: 30 received amoxicillin, 28 received amoxicillin-clavulanate potassium, and 35 received placebo. Clinical assessment was performed at three and ten days. On each occasion, children treated with an antibiotic were more likely to be cured than children receiving placebo (P < .01 at three days, P < .05 at ten days). The overall cure rate was 67% for amoxicillin, 64% for amoxicillin-clavulanate potassium, and 43% for placebo.

Download Full-text

Awareness Is Not Enough: A Double-Blind Randomized Controlled Trial of the Effects of Providing Discipline Disproportionality Data Reports to School Administrators

Educational Researcher ◽

10.3102/0013189x20939937 ◽

2020 ◽

Vol 49 (7) ◽

pp. 533-537

Author(s):

Kent McIntosh ◽

Keith Smolkowski ◽

Cody M. Gion ◽

Lauren Witherspoon ◽

Eoin Bastable ◽

...

Keyword(s):

Randomized Controlled Trial ◽

School Improvement ◽

School Administrators ◽

Controlled Trial ◽

School Improvement Plan ◽

Double Blind ◽

Racial Disproportionality ◽

Randomized Controlled ◽

Discipline Disproportionality ◽

To Receive

One commonly used strategy used in attempts to decrease racial disproportionality in school discipline across the country is sharing data with school administrators that discipline disparities are a problem in their schools with the assumption that it will increase attention to equity and improve outcomes. The purpose of this study was to assess the effects of providing monthly disciplinary equity reports to school administrators in 35 schools on levels of (a) disciplinary equity report viewing, (b) disciplinary equity, and (c) inclusion of disciplinary equity into school improvement plan goals. We used a small, double-blind randomized controlled trial in which half of the schools were randomly assigned to receive either monthly disciplinary equity reports or monthly general discipline reports. Results showed that schools receiving the equity reports had significantly increased rates of viewing equity reports but no meaningful change in disciplinary equity or equity goal setting.

Download Full-text

A randomized, double-blind trial of fluorouracil plus placebo versus fluorouracil plus oral leucovorin in patients with metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1993.11.10.1888 ◽

1993 ◽

Vol 11 (10) ◽

pp. 1888-1893 ◽

Cited By ~ 44

Author(s):

L R Laufman ◽

R M Bukowski ◽

M A Collier ◽

B A Sullivan ◽

R A McKinnis ◽

...

Keyword(s):

Colorectal Cancer ◽

Treatment Failure ◽

Metastatic Colorectal Cancer ◽

Response Rate ◽

Controlled Trial ◽

Double Blind ◽

Time To Treatment Failure ◽

To Receive ◽

Toxicity Pattern

PURPOSE A prospectively randomized trial was performed to determine whether the combination of fluorouracil (FU) plus leucovorin (FU-LV) administered orally is more effective than equitoxic FU for patients with metastatic colorectal cancer. PATIENTS AND METHODS A double-blind, placebo-controlled trial design was used to eliminate observer bias. An escalating FU dosing schedule was used to achieve equal toxicity. End points were response, time to treatment failure (TTF), and eight quality-of-life (QL) parameters. A crossover arm allowed FU-treated patients to receive FU-LV combination treatment after treatment failure. RESULTS Response rate was 32% for FU-LV versus 23% for FU (P = .15). Median TTF was 22 versus 16 weeks (P = .27). Median survival time was 44 versus 54 weeks (P = .26). QL was the same for both treatments, except for days of hospitalization, which was greater for FU-LV (P < .001). Toxicities were similar to those previously reported for FU-LV and FU alone. CONCLUSION Oral LV-FU produces the same efficacy and toxicity pattern as has been reported for intravenous LV-FU. When FU-LV is compared with equitoxic doses of FU, there is no difference in patient outcome. These results suggest that patients with advanced disease should receive FU at doses adequate to produce toxicity.

Download Full-text

Efficacy of Standardized Extract ofBacopa monnieri(Bacognize®) on Cognitive Functions of Medical Students: A Six-Week, Randomized Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2016/4103423 ◽

2016 ◽

Vol 2016 ◽

pp. 1-8 ◽

Cited By ~ 13

Author(s):

Navneet Kumar ◽

L. G. Abichandani ◽

Vijay Thawani ◽

K. J. Gharpure ◽

M. U. R. Naidu ◽

...

Keyword(s):

Medical Students ◽

Cognitive Functions ◽

Controlled Trial ◽

Bacopa Monnieri ◽

Normal Range ◽

Double Blind ◽

Double Blind Placebo ◽

Medical College ◽

Second Year ◽

To Receive

Rationale.Bacopa monnieri, popularly known as Brahmi, has been traditionally used in Ayurveda since ages for its memory enhancing properties. However, data on placebo-controlled trial ofBacopa monnierion intellectual sample is scarce. Hence this study was planned to evaluate the effect ofBacopa monnierion memory of medical students for six weeks.Objective. To evaluate the efficacy ofBacopa monnierion memory of medical students with six weeks’ administration.Method and Material. This was a randomized double blind placebo-controlled noncrossover, parallel trial. Sixty medical students of either gender from second year of medical school, third term, regular batch, were enrolled from Government Medical College, Nagpur, India. Baseline biochemical and memory tests were done. The participants were randomly divided in two groups to receive either 150 mg of standardized extract ofBacopa monnieri(Bacognize) or matching placebo twice daily for six weeks. All baseline investigations were repeated at the end of the trial. Students were followed up for 15 days after the intervention.Results. Statistically significant improvement was seen in the tests relating to the cognitive functions with use ofBacopa monnieri. Blood biochemistry also showed a significant increase in serum calcium levels (still within normal range).

Download Full-text