Objective: The purpose of this observation was to evaluate the safety and efficacy of hydrocortisone (HC) for the treatment of refractory hypotension in term and preterm infants. A secondary purpose was to determine the utility of serum cortisol concentrations in predicting the response to treatment.Study Design: This is a retrospective observational study of 117 infants treated with a standardized HC protocol for refractory hypotension. Refractory hypotension was defined as a mean arterial pressure (MAP) less than the gestational age (GA) despite a total inotrope dose of 20 mg per kg per min. Baseline serum cortisol concentrations were determined prior to treatment with stress dose HC.Result: Treatment with HC increased the MAP at 2, 6, 12 and 24 h after initiation, decreased the total inotrope dose at 6, 12 and 24 h, and was associated with resolution of oliguria. There was no correlation between the pretreatment baseline cortisol concentration and GA, birth weight or the response to treatment. The incidence of grades III to IV intraventricular hemorrhage, periventricular leukomalacia, bacterial or fungal sepsis and spontaneous intestinal perforation (SIP) after HC treatment was similar to institutional historic controls prior to institution of this standardized HC protocol.Conclusion: HC treatment was associated with a rapid resolution of cardiovascular compromise. The incidence of significant side effects was similar to that in previously published reports, including a comparable incidence of SIP. On the basis of our results, measuring baseline serum cortisol concentration to guide the management of refractory hypotension is unwarranted.
BACKGROUND The objectives of the current study were to evaluate the safety and efficacy of gemcitabine plus docetaxel in patients with unresectable (Stage T4 or ≥ N1) metastatic or locally advanced transitional cell carcinoma (TCC) of the urothelial tract. METHODS A total of 27 patients were enrolled in the current multisite study, which was performed within the University of California‐Los Angeles Community Oncology Research Network. The first 10 patients in the study received 800 mg/m2 of gemcitabine intravenously on Days 1, 8, and 15 of a 28‐day treatment cycle. In addition, on Day 1, the first 10 patients received 80 mg/m2 of docetaxel intravenously after completion of the gemcitabine infusion. Because of dose‐limiting toxicity (neutropenia), the initial dose of docetaxel was reduced to 60 mg/m2 for the remaining patients who entered the study (n = 17 patients). RESULTS Neutropenia was the most common adverse event that occurred in patients at the Grade 3 level (in 10 of 27 patients; 37.0%) and the Grade 4 level (in 6 of 27 patients; 22.2%). There were no other adverse events at the Grade 4 toxicity level. Twenty‐five of 27 patients (92.6%) completed more than 1 cycle of combination therapy and were evaluated for antitumor responses. The frequency of objective clinical responses was 33.3% (9 of 27 patients). Complete responses to therapy were observed in 2 of 27 patients (7.4%), and partial responses were observed in 7 of 27 patients (25.9%). The median duration of response was 20 weeks (range, 12+ weeks to 152 weeks). The median survival duration was 52 weeks (range, 12 weeks to 160+ weeks). Four of 27 patients (14.8%) remained alive at the time of the current data analysis. CONCLUSIONS The results of the current study suggested that combination therapy with gemcitabine and docetaxel was an effective treatment for patients with unresectable (Stage T4 or ≥ N1) metastatic or locally advanced TCC of the urothelial tract. Gemcitabine plus docetaxel appeared to be tolerated well, and treatment‐related toxicities were limited to hematologic toxicities. Because cisplatin‐containing regimens are contraindicated for patients with impaired renal function, the gemcitabine plus docetaxel combination may prove to be an effective and well tolerated treatment option for these patients. Cancer 2003. © 2003 American Cancer Society.
We report a case of oral acetaminophen toxicity in a term newborn infant successfully treated with a 20 h intravenous N-acetylcysteine infusion protocol without any adverse effects. This case report supports the use of N-acetylcysteine to treat neonatal acetaminophen toxicity and highlights the need for better education of parents regarding the appropriate use and dosage of acetaminophen in newborns. Journal of Perinatology (2007Perinatology ( ) 27, 133-135. doi:10.1038 Keywords: Neonatal acetaminophen toxicity; hepatic failure; N-acetylcysteine IntroductionAcetaminophen is an efficacious and safe analgesic used often in newborns. 1 Although it is relatively safe, acetaminophen toxicity is well documented and can lead to liver failure and even death. The risk of developing toxicity is, in general, thought to be lower in children than in adults. N-acetylcysteine (NAC) is the treatment of choice for acetaminophen overdose in older children and adults. To date, there are no documented neonatal cases of oral acetaminophen toxicity with hepatic encephalopathy. We report a case of oral acetaminophen toxicity presenting with hepatic encephalopathy and oliguric renal failure in a term newborn infant successfully treated with intravenous NAC without observable adverse effects.Case report A four day-old term male infant was brought to the emergency department after episodic emesis and decreased level of arousal. He was born to a 24 year-old mother following an uncomplicated pregnancy by normal spontaneous vaginal delivery at 41 weeks gestational age. Apgar scores were 9 at 1 min and 9 at 5 min. He was discharged on the second postnatal day after circumcision.One day later he became sleepy, fed poorly and vomited approximately 10 times in 24 h. The baby was evaluated by a visiting nurse, who sent him to the emergency department. On examination he was moderately dehydrated, lethargic and poorly responsive to stimulation. Gastric lavage produced blood-tinged aspirates. Significant laboratory findings included glucose 27 mg/dl (normal: 45 to 120 mg/dl), Na 149 mEq/l (normal: 135 to 148 mEq/l), K 5.9 mEq/l, Cl 110 mEq/l (normal: 91 to 111 mEq/l), CO 2 18 mEq/l, BUN 40 mg/dl, creatinine 3.2 mg/dl (normal: 0.3 to 1 mg/dl), total serum bilirubin 9 mg/dl with a conjugated fraction of 1.4 mg/dl, serum ammonia 114 mmol/l (normal: 56 to 92 mmol/l), AST 718 IU/l (normal: 20 to 65 IU/l), ALT 978 IU/l (normal: <54 IU/L), PT 51.9 s (normal; 10.1 to 15.9 s), PTT 45.7 s (normal: 31.3 to 54.3 s), INR 5.4 (normal: 0.96 to 1.04), D-dimer 5.9 mg/l, factor V assay 57% and fibrinogen 61 mg/dl (normal: 1.67 to 3.09 g/l). A complete blood count revealed a WBC count of 13 600/mm, 2 hematocrit 66.4% and platelets of 154 000/mm. 3 Cerebral spinal fluid analysis was normal. The baby received intravenous volume expansion, dextrose and ampicillin and cefotaxime. He was admitted to the neonatal intensive care unit with a presumptive diagnosis of sepsis with renal failure, liver failure and coagulopathy. An arterial blood gas analysis after fluid boluses ...
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