Trial Files Throwback Thursday: Albumin for Large-Volume Paracentesis, Target BP in Pregnancy, and Early Combination Therapy for RA

Apr 4, 2024

Why should I give albumin after large-volume paracentesis in patients with cirrhosis?

Randomized comparative study of therapeutic paracentesis with and without intravenous albumin in cirrhosis

Ginès P et al. Gastroenterology (June 1988)

Bottom line: This randomized controlled trial investigated the necessity of intravenous albumin infusion in the treatment of cirrhosis with large-volume paracentesis for tense ascites. 105 patients were allocated into two groups, with one group (n = 52) receiving paracentesis (4-6 L/day until disappearance of ascites) plus albumin infusion (40 g after each tap) and the other (n = 53) receiving paracentesis alone. The primary outcome of ascites elimination was found to be effective in both groups, with no significant difference between them. However, the group that received paracentesis without albumin infusion had increased risks of renal impairment and hyponatremia, with 1 patient from the experimental group and 11 from the control group developing one or both of these complications after treatment (chi 2 = 9.19; p less than 0.01). Survival analysis showed that the development of these complications was the only independent predictor of mortality. Therefore, the study concluded that intravenous albumin infusion is important in preventing renal and electrolyte complications in patients with cirrhosis and ascites treated with large-volume paracentesis.

LINK TO ARTICLE (Ginès et al.)

What’s the evidence behind the diastolic blood pressure target of <85 mmHg in hypertension during pregnancy?

Less-Tight versus Tight Control of Hypertension in Pregnancy (CHIPS)

Magee L et al. NEJM (January 2015)

Bottom Line: This open, international, multicenter trial included 987 pregnant patients between 14 weeks 0 days to 33 weeks 6 days of gestation with nonproteinuric preexisting or gestational hypertension, office diastolic blood pressure (DBP) of 90-105 or 85-105 if taking antihypertensive medication, and a live fetus. Participants were randomly assigned to less-tight control (target DBP, 100 mm Hg) or tight control (target DBP, 85 mm Hg). The composite primary outcome included pregnancy loss or high-level neonatal care within 28 postnatal days and the secondary outcome was serious maternal complications up to the later of 6 weeks post-partum or hospital discharge. Primary outcome rates were comparable among the 493 patients in the less-tight control group and 488 patients in the tight control group (31.4% and 30.7%, respectively; adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.77 to 1.35). Despite mean DBP being 4.6 mmHg higher in the less-tight control group (95% CI, 3.7 to 5.4), rates of serious maternal complications were similar at 3.7 and 2.0 respectively (adjusted odds ratio, 1.74; 95% CI, 0.79 to 3.84). However, the less-tight control group had a higher frequency of severe maternal hypertension (≥160/110 mm Hg) of 40.6% compared to 27.5% in the tight-control group (P<0.001). Thus, the study did not find any significant differences in pregnancy loss, high-level neonatal care, or overall maternal complications between the two control groups, though less tight control was associated with increased frequency of severe maternal hypertension.

LINK TO ARTICLE (Magee et al.)

What’s the rationale for starting combination therapy early in rheumatoid arthritis?

Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study)

Goekoop-Ruiterman Y et al. Arthritis Rheum. (November 2005)

Bottom Line: This multicenter randomized clinical trial compared four different treatment strategies for early rheumatoid arthritis (RA) in 508 patients. The intervention groups included initial combination therapy with either prednisone or infliximab, while the comparator groups were sequential monotherapy or step-up combination therapy. Treatment adjustments were made every 3 months in an effort to obtain low disease activity. The Dutch version of the Health Assessment Questionnaire (D-HAQ) was used to measure patient response. After 1 year, the intervention groups showed earlier functional improvement and less radiographic damage compared to the comparator groups, with mean D-HAQ scores of 0.7 compared to 0.5 in the comparator groups. The intervention groups had median increases in total Sharp/Van der Heijde radiographic joint score of 2.0 and 2.5 while the comparator group had scores of 1.0 and 0.5 (P<0.001). There were no significant differences in adverse events and withdrawals between groups. This study suggests that initial combination therapy with prednisone or infliximab may be more effective in improving outcomes for patients with early RA.

LINK TO ARTICLE (Goekoop et al.)


Trial Files Issue #2024-07