https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(09)61069-2.pdf

Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial.

Purpose Gemcitabine as a single agent and the combination of gemcitabine and docetaxel have activity in patients with metastatic soft tissue sarcoma. To determine if the addition of docetaxel to gemcitabine improved clinical outcome of patients with metastatic soft tissue sarcomas, we compared a fixed dose rate infusion of gemcitabine versus a lower dose of gemcitabine with docetaxel. Patients and Methods In this open-label phase II clinical trial, the primary end point was tumor response, defined as complete or partial response or stable disease lasting at least 24 weeks. A Bayesian adaptive randomization procedure was used to produce an imbalance in the randomization in favor of the superior treatment, accounting for treatment-subgroup interactions. Results One hundred nineteen of 122 randomly assigned patients had assessable outcomes. The adaptive randomization assigned 73 patients (60%) to gemcitabine-docetaxel and 49 patients (40%) to gemcitabine alone, indicating gemcitabine-docetaxel was superior. ...

https://ascopubs.org/doi/pdf/10.1200/JCO.2006.10.4117

Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas

Thirty-nine newborn infants with severe persistent pulmonary hypertension and respiratory failure who met criteria for 85% likelihood of dying were enrolled in a randomized trial in which extracorporeal membrane oxygenation (ECMO) therapy was compared with conventional medical therapy (CMT). In phase I, 4 of 10 babies in the CMT group died and 9 of 9 babies in the ECMO group survived. Randomization was halted after the fourth CMT death, as planned before initiating the study, and the next 20 babies were treated with ECMO (phase II). Of the 20, 19 survived. All three treatment groups (CMT and ECMO in phase I and ECMO, phase II) were comparable in severity of illness and mechanical ventilator support. The overall survival of ECMO-treated infants was 97% (28 of 29) compared with 60% (6 of 10) in the CMT group (P less than .05).

Extracorporeal membrane oxygenation and conventional medical therapy in neonates with persistent pulmonary hypertension of the newborn: a prospective randomized study.

Objective:
Severe acute respiratory distress syndrome (ARDS) is associated with a high level of mortality. Extracorporeal life support (ECLS) during severe ARDS maintains oxygen and carbon dioxide gas exchange while providing an optimal environment for recovery of pulmonary function. Since 1989, we have used a protocol-driven algorithm for treatment of severe ARDS, which includes the use of ECLS when standard therapy fails. The objective of this study was to evaluate our experience with ECLS in adult patients with severe ARDS with respect to mortality and morbidity.

Extracorporeal Life Support for Severe Acute Respiratory Distress Syndrome in Adults

The University of Michigan experience with extracorporeal life support
(ECLS) in 1000 consecutive patients between 1980 and 1998 is the largest series
at one institution in the world. Among this patient population, survival to
hospital discharge in moribund patients with respiratory failure was 88% in
586 neonates, 70% in 132 children, and 56% in 146 adults. Survival in moribund
patients with cardiac failure was 48% in 105 children and 33% in 31 adults.
This article describes the University of Michigan's overall ECLS patient experience,
the progression of ECLS from laboratory experiments to clinical application
at the bedside, the expansion of the technology to other centers, and current
ECLS technology and outcomes. Despite the challenges faced in clinical research
in this field, our experience and that of others has shown that ECLS saves
lives of patients with acute cardiac or pulmonary failure in a variety of
clinical settings.

https://jamanetwork.com/journals/jama/articlepdf/192408/JSC90349.pdf

D.W. Roloff

Papers

Extracorporeal circulation in neonatal respiratory failure: A prospective randomized study