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Biomedical subjects

D P Wermeling

Publications and source records attributed to D P Wermeling.

26 records · Page 2Linked to original sources
PubMed1987

Pentobarbital pharmacokinetics in patients with severe head injury.

Intravenous administration of high-dose pentobarbital has been proposed as a treatment for elevated intracranial pressure refractory to other measures in brain-injured patients. The purpose of this clinical study was to examine the pharmacokinetics of high-dose continuous intravenous infusion of pentobarbital in this critical care setting. Six patients received a 25-34 mg/kg intravenous loading dose followed by a 1-3 mg/kg/h continuous infusion for 61-190 hours. Dosing rates were adjusted based on the patient's clinical status. The mean clearance was 0.72 ml/min/kg, with a volume of distribution (Vd) of 1.03 L/kg and a terminal half-life of 19.1 h. Considerable variation in individual patient parameters was observed. In addition, a change in clearance was suggested in patients requiring a longer infusion duration.

Adolescent↗
PubMed1987

Evaluation of a disposable, nonelectronic, patient-controlled-analgesia device for postoperative pain.

The safety and efficacy of a disposable, nonelectronic, patient-controlled-analgesia (PCA) device for alleviating postoperative pain were evaluated. Patients who were to undergo abdominal surgical procedures under general anesthesia were instructed in the use of the Travenol Infusor with Patient Control Module. Patients used the PCA device upon emerging from anesthesia in the recovery room. The PCA device delivered a 1-mg i.v. injection of morphine sulfate upon patient demand, with a relative delay of six minutes between allowable administrations. Nursing staff evaluated pain and sedation every four hours using a five-point scale. In the 50 patients evaluated, the highest analgesic use occurred during the first four to eight postoperative hours. After the immediate postoperative period, patients experienced either mild or no pain during approximately 90% of the evaluation periods. No patient suffered respiratory depression during self-dosing. Results of a poststudy self-assessment questionnaire showed that 90% of the patients reported experiencing mild to moderate pain overall, and 78% reported only mild discomfort throughout the postoperative period. Ninety-two percent of the patients strongly preferred PCA therapy over intramuscular injections. The Travenol Infusor with Patient Control Module represents a safe and effective device for PCA therapy of postoperative pain.

Abdomen↗
PubMed1985

Osmolality of small-volume intravenous admixtures.

Osmolalities of commonly administered small-volume i.v. admixtures were determined, and use of diluents with lower osmolality to achieve osmolality values less than 400 mOsm/kg was studied. The theoretical osmolality of 218 hypothetical admixtures of various concentrations of 34 injectable drugs in 50- or 100-mL quantities of 5% dextrose injection or 0.9% sodium chloride injection was calculated using sodium chloride equivalents. If the calculated osmolality value was greater than 400 mOsm/kg, an actual admixture was prepared and osmolality and density were measured. To determine how admixtures with osmolality values less than 400 mOsm/kg could be prepared, theoretical osmolality was calculated using 0.45% sodium chloride injection or sterile water for injection as the diluent. The calculated osmolality value was greater than 400 mOsm/kg for 52 (23.9%) of the 218 admixtures tested. Of the 52 measured osmolality values, 47 were within 15% of the calculated value. Calculated osmolality values for all admixtures were less than 400 mOsm/kg when 0.45% sodium chloride injection or sterile water for injection was used as the diluent. Admixture osmolality should be considered when preparing drugs for i.v. injection. For drugs with high osmolalities, 0.45% sodium chloride injection or sterile water for injection may be used as the diluent.

Anti-Bacterial Agents↗
PubMedDate not supplied

Current issues surrounding women and minorities in drug trials.

OBJECTIVE: Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last decade certain segments of society, particularly women and minorities, have demanded greater participation in clinical drug trials and earlier access to investigational drug therapies. Regulations that have served the clinical research community (pharmaceutical industry, investigators, institutional review boards) as guidelines for safe conduct of human clinical trials are being challenged by social and political change. This article provides an overview of some of the controversy relative to federal regulations governing clinical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research. DATA SOURCES: Literature for this paper was retrieved from a variety of sources including the nonmedical press, editorials, peer-reviewed journals, Department of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration. DATA SYNTHESIS: Scientists evaluating new therapeutic agents ask specific research questions to assess safety, efficacy, and the mechanism(s) of action. Because of concerns for scientific validity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ultimate users of a new drug. Federal regulations and ethical principles allow certain groups of people to be excluded from early research proposals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, and other populations are demanding greater access to investigational drugs. The focus has changed from protection from research risks and burdens to the potential benefits a person or class of people may obtain by participating in a study. CONCLUSIONS: Scientists, the pharmaceutical industry, regulators, and society must agree on a safe and efficient mechanism for new drug development that permits more equitable participation of subjects in the various phases of research.

Clinical Trials as Topic↗
PubMedDate not supplied

Effects of long-term oral carvedilol on the steady-state pharmacokinetics of oral digoxin in patients with mild to moderate hypertension.

The effect of multiple oral doses of carvedilol on steady-state plasma digoxin pharmacokinetics was evaluated in 12 patients with mild to moderate hypertension. Area under the curve (AUC), mean maximum plasma concentration (Cmax), mean time to maximum concentration (Tmax), concentration at 24 hours after the dose (C24), creatinine clearance, renal digoxin clearance, and urinary digoxin excretion were determined after patients took oral digoxin 0.25 mg once/day for 2 weeks. Carvedilol was added to the regimen, and digoxin pharmacokinetics were assessed after 2 weeks of concurrent treatment. The AUC and Cmax for digoxin increased by 14% and 32%, respectively (p < 0.05), with no change in Tmax. The 24-hour urinary digoxin excretion and 24-hour renal digoxin clearance increased by 45% and 26%, respectively (p < 0.05), with no change in creatinine clearance. Carvedilol appears to increase digoxin's oral bioavailability as well as renal elimination. The absolute change in digoxin pharmacokinetics was small and not clinically significant. The significance of the interaction in other patient populations remains to be studied.

Administration, Oral↗
PubMedDate not supplied

Seizures in patients receiving concomitant antimuscarinics and acetylcholinesterase inhibitor.

Seizures occurred in two patients with probable Alzheimer's disease who were receiving long-term treatment with metrifonate, an irreversible acetylcholinesterase inhibitor. In both patients seizures were associated with discontinuation of short-term agents with high antimuscarinic properties. Hence, abrupt discontinuation of antimuscarinics or anticholinergics with high antimuscarinic properties in patients receiving long-term acetylcholinesterase inhibition therapy may be associated with a reduction of seizure threshold. With increasing administration of acetylcholinesterase inhibitors for patients with Alzheimer's disease, practitioners should be aware of the potential for drug-drug interactions and other complications. In general, it is good medical practice to avoid concomitant administration with centrally acting anticholinergic agents.

Aged↗