scholarly journals Assessing the progression of renal disease in clinical studies: effects of duration of follow-up and regression to the mean. Modification of Diet in Renal Disease (MDRD) Study Group.

1991 ◽  
Vol 1 (9) ◽  
pp. 1087-1094 ◽  
Author(s):  
A S Levey ◽  
J J Gassman ◽  
P M Hall ◽  
W G Walker

Many clinical studies of the effects of low-protein and low-phosphorus diets on the course of chronic renal disease have used the rate of decline in renal function to assess the rate of progression. In this report, data from the feasibility phase of the Modification of Diet in Renal Disease Study were used to analyze methods used in other studies. The focus is particularly on the effects of duration of follow-up and of regression to the mean. The findings are summarized as follows. (1) During the mean follow-up period of 14.1 months, rates of decline in glomerular filtration rate, creatinine clearance, and the reciprocal of the serum creatinine concentration were highly variable among individuals, and mean rates of decline were slow. (2) Precision of estimates of individual rates of decline in renal function were relatively low and improved with increasing duration of follow-up. (3) Correlations between rates of decline in creatinine clearance and the reciprocal of the serum creatinine concentration with glomerular filtration rate in individuals were significant but weak and became stronger with increasing duration of follow-up. (4) After entry into the study, mean rate of decline in the reciprocal of the serum creatinine concentration became less negative. The change predicted simply from regression to the mean was 68.4% of the observed change.(ABSTRACT TRUNCATED AT 250 WORDS)


2007 ◽  
Vol 51 (6) ◽  
pp. 1912-1917 ◽  
Author(s):  
Nenad Sarapa ◽  
Prachi Wickremasingha ◽  
NanXiang Ge ◽  
Richard Weitzman ◽  
Merynda Fuellhart ◽  
...  

ABSTRACT DX-619 is a novel des-fluoro(6)-quinolone with activity against a broad range of bacterial strains, including methicillin-resistant Staphylococcus aureus. The effects of DX-619 on the glomerular filtration rate (GFR) were evaluated because drug-related increases in serum creatinine levels were observed in studies with healthy volunteers. Forty-one healthy subjects were randomized to receive intravenous DX-619 at 800 mg or placebo once daily for 4 days, and the GFR was directly measured by determination of the clearance of a bolus iohexol injection in 33 subjects who completed the study per protocol. DX-619 was noninferior to placebo for the GFR on the basis of a criterion for a clinically significant difference of −12 ml/min/1.73 m2. The mean GFRs on day 4 were 101.1 ± 14.2 ml/min/1.73 m2 and 100.2 ± 15.6 ml/min/1.73 m2 for the volunteers receiving placebo and DX-619, respectively. On day 4 the mean serum creatinine concentration for volunteers receiving DX-619 increased by 30 to 40%, with a corresponding decrease in mean creatinine clearance. Both parameters normalized within 7 days after the cessation of DX-619 treatment. Nonclinical studies suggest that DX-619 increases the serum creatinine concentration by inhibiting excretory tubular transporters. In conclusion, DX-619 administered intravenously at 800 mg once a day for 4 days did not affect the GFR in healthy volunteers. Glomerular toxicity is not expected to present a risk to patients receiving DX-619 in clinical trials, but monitoring of the renal function, with an emphasis on the serum creatinine concentration, is still warranted.



2001 ◽  
Vol 12 (7) ◽  
pp. 1475-1481
Author(s):  
JAAP J. BEUTLER ◽  
JACOBINE M. A. VAN AMPTING ◽  
PETER J. G. VAN DE VEN ◽  
HEIN A. KOOMANS ◽  
FREDERIK J. A. BEEK ◽  
...  

Abstract. It is uncertain whether renal artery stent placement in patients with atherosclerotic renovascular renal failure can prevent further deterioration of renal function. Therefore, the effects of renal artery stent placement, followed by patency surveillance, were prospectively studied in 63 patients with ostial atherosclerotic renal artery stenosis and renal dysfunction (i.e., serum creatinine concentrations of >120 μmol/L (median serum creatinine concentration, 171 μmol/L; serum creatinine concentration range, 121 to 650 μmol/L). Pre-stent renal (dys) function was stable for 28 patients and declining for 35 patients (defined as a serum creatinine concentration increase of ≥20% in 12 mo). The median follow-up period was 23 mo (interquartile range, 13 to 29 mo). Angioplasty to treat restenosis was performed in 12 cases. Five patients reached end-stage renal failure within 6 mo, and this was related to stent placement in two cases. Two other patients died or were lost to follow-up monitoring within 6 mo, with stable renal function. For the remaining 56 patients, the treatment had no effect on serum creatinine levels if function had previously been stable; if function had been declining, median serum creatinine concentrations improved in the first 1 yr [from 182 μmol/L (135 to 270 μmol/L) to 154 μmol/L (127 to 225 μmol/L); P < 0.05] and remained stable during further follow-up monitoring. In conclusion, stent placement, followed by patency surveillance, to treat ostial atherosclerotic renal artery stenosis can stabilize declining renal function. For patients with stable renal dysfunction, the usefulness is less clear. The possible advantages must be weighed against the risk of renal failure advancement with stent placement.



1992 ◽  
Vol 38 (10) ◽  
pp. 1933-1953 ◽  
Author(s):  
R D Perrone ◽  
N E Madias ◽  
A S Levey

Abstract The serum creatinine concentration is widely interpreted as a measure of the glomerular filtration rate (GFR) and is used as an index of renal function in clinical practice. Glomerular filtration of creatinine, however, is only one of the variables that determines its concentration in serum. Alterations in renal handling and metabolism of creatinine and methodological interferences in its measurement may have a profound impact on the serum concentration of creatinine. We review the fundamental principles of physiology, metabolism, and analytical chemistry that are necessary to correctly interpret the serum creatinine concentration. These principles are then applied to important clinical circumstances, including aging, pregnancy, diabetes mellitus, drug administration, and acute and chronic renal failure. Despite numerous limitations, serum creatinine remains a useful clinical tool, but more accurate measures of renal function are frequently necessary.



2000 ◽  
Vol 35 (2) ◽  
pp. 176-181 ◽  
Author(s):  
Leanne D. Kennedy ◽  
Julie F. Connelly ◽  
Kevin M. Kuzma

A 2-year concurrent drug use evaluation was conducted in 156 patients to determine whether Abelcet (amphotericin B lipid complex injection) was being prescribed according to institution-approved guidelines and to characterize the patient population receiving Abelcet. Eighty-nine patients (57%) had fungal infections documented by chest x-ray, computed tomography, or fungal cultures. Sixty-seven (43%) had clinically suspected fungal infections. The Abelcet mean dose by weight was 5 mg/kg/day (actual body weight). Seventy-one patients (46%) met the established guidelines for use; 85 (54%) did not. Premedication was given to 64% of the patients; only 15 patients (10%) experienced documented fever and chills. A total of 72 patients (46%) died during therapy. Of the 75 patients who completed therapy in the hospital, 41 were switched to conventional amphotericin B, fluconazole, or itraconazole following a decrease in serum creatinine concentration, and 34 did not receive further antifungal therapy. The mean length of Abelcet therapy was 11 days. The mean increase in serum creatinine concentration at discontinuation of therapy was 0.2 mg/dL. Continued monitoring of Abelcet use was recommended and established guidelines were reaffirmed. Hydration with normal saline before and after dosing was suggested to help improve renal function, and dopamine was recommended to increase renal blood flow.



1977 ◽  
Vol 11 (1) ◽  
pp. 62-70 ◽  
Author(s):  
W. Ernest Rutherford ◽  
Joan Blondin ◽  
J. Philip Miller ◽  
Allen S. Greenwalt ◽  
John D. Vavra


2012 ◽  
Vol 130 (5) ◽  
pp. 289-293 ◽  
Author(s):  
Alexandre Libório ◽  
Russian Uchoa ◽  
João Neto ◽  
Juan Valdivia ◽  
Elizabeth De Francesco Daher ◽  
...  

CONTEXT AND OBJECTIVE: Severe heart failure is highly associated with chronic kidney disease (CKD). Serum creatinine is a poor indicator of renal function and glomerular filtration rate (GFR) estimation is an accessible method for assessing renal function. The most popular formulas for GFR estimation are the Cockcroft-Gault (CG), the four-variable Simplified Modification of Diet in Renal Disease (sMDRD) and the recently introduced CKD-Epidemiology Collaboration (CKD-EPI). The objective of the study was to analyze the correlation between these three equations for estimating GFR in patients with severe heart failure. DESIGN AND SETTING: Cross-sectional observational study at a university reference center. METHODS: GFR was estimated in patients with severe heart failure who were awaiting heart transplantation, using the CG, sMDRD and CKD-EPI formulas. These estimates were analyzed using Pearson's correlation and Bland-Altman analysis. RESULTS: This study included 157 patients, of whom 32 (20.3%) were female. Normal serum creatinine concentration was observed in 21.6%. The mean GFR according to CG, sMDRD and CKD-EPI was 70.1 ± 29.5, 70.7 ± 37.5 and 73.7 ± 30.1 ml/min/1.73 m²; P > 0.05. Pearson's coefficient demonstrated good correlations between all the formulas, as did Bland-Altman. However, the patients presented GFR < 60 ml/min more frequently with the sMDRD formula (54.1% versus 40.2% for CG and 43.2% for CKD-EPI; P = 0.02). CONCLUSION: Despite the good correlation and agreement between the three methods, the sMDRD formula classified more patients as presenting GFR less than 60 ml/min.



1983 ◽  
Vol 29 (1) ◽  
pp. 205-208 ◽  
Author(s):  
A H WU ◽  
R Stout ◽  
R B McComb

Abstract A case of severe methanol intoxication (1300 mg/L) was associated with markedly increased serum creatinine (490 mg/L) despite normal urea values and the absence of any other signs of renal disease. These values declined progressively to normal, and the patient recovered with no visual impairment. Additional laboratory experimentation suggested that the high creatinine value was probably ascribable to some unknown foreign material(s) in the patient's blood that reacted with the alkaline picrate used in the measurement of creatinine. One of the presumed metabolites of methanol, formaldehyde, reacts with creatinine but the product does not react with picrate. We believe that the foreign material was derived from either commercial preparations of methanol or contaminants in the patient's drinking water.



BMJ ◽  
1983 ◽  
Vol 286 (6366) ◽  
pp. 684-685 ◽  
Author(s):  
O Nived ◽  
G Sturfelt ◽  
H Westling ◽  
T White


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