Clinical investigation of renal disease

2010 ◽  
pp. 3863-3884
Author(s):  
A. Davenport
Keyword(s):  
Specific Gravity ◽  
Renal Disease ◽  
Clinical Investigation ◽  
Early Morning ◽  
Red Cells ◽  
Careful Examination ◽  
Macroscopic Appearance ◽  
Heavy Proteinuria ◽  
Clinical Investigations ◽  
Standard Investigation

An accurate history and careful examination will determine the sequence and spectrum of clinical investigations required to make a diagnosis or decide on prognosis or treatment. Midstream urine (MSU) sample—this standard investigation requires consideration of: (1) macroscopic appearance—this may be suggestive of a diagnosis, e.g. frothy urine suggests heavy proteinuria; (2) stick testing—including for pH (<5.3 in an early-morning specimen makes a renal acidification defect unlikely), glycosuria, specific gravity (should be >1.024 in an early-morning or concentrated sample), nitrite (>90% of common urinary pathogens produce nitrite) and leucocyte esterase; and (3) microscopy—for cellular elements (in particular red cells, with the presence of dysmorphic red cells detected by experienced observers indicative of glomerular bleeding), casts (cellular casts indicate renal inflammation), and crystals....

Clinical investigation of renal disease

2020 ◽  
pp. 4781-4806
Author(s):  
Andrew Davenport
Keyword(s):  
Renal Impairment ◽  
Renal Disease ◽  
Clinical Investigation ◽  
Multislice Ct ◽  
Clinical Information ◽  
Distal Tubule ◽  
Ct Scanning ◽  
Careful Examination ◽  
Positron Emission ◽  
Retrograde Ureteropyelography

An accurate history and careful examination will determine the sequence and spectrum of clinical investigations required to make a diagnosis or decide on prognosis or treatment for renal disease. Midstream urine (MSU) sample—this standard investigation requires consideration of (1) macroscopic appearance, (2) stick testing, and (3) microscopy. Quantification of proteinuria—this is important because the risk for progression of underlying kidney disease to endstage renal failure is related to the amount of protein in the urine. Low molecular weight proteinuria is caused by proximal tubular injury and can be detected with markers. Knowledge of the glomerular filtration rate (GFR) is of crucial importance in the management of patients, not only for detecting the presence of renal impairment, but also in the monitoring of all patients with or at risk of renal impairment, and in determining appropriate dosing of those drugs cleared by the kidney. Measurement of plasma creatinine remains the standard biochemical test used to assess renal function. The simplified Modification of Diet in Renal Disease (sMDRD) formula is explained, along with a revised version (CKD-EPI). Investigations of tubular function, including the proximal tubule, distal tubule, and renal-induced electrolyte and acid–base imbalances are discussed in this chapter. Renal imaging covered in this chapter includes ultrasonography, ultrafast multislice CT scanning, magnetic resonance imaging, nuclear medicine scanning, and fluorodeoxyglucose positron emission tomography. Invasive techniques including antegrade or retrograde ureteropyelography and angiography are discussed. A renal biopsy should be considered in any patient with disease affecting the kidney when the clinical information and other laboratory investigations have failed to establish a definitive diagnosis or prognosis, or when there is doubt as to the optimal therapy.

Skin Examination: An Important Diagnostic Tool in Renal Failure Patients

2018 ◽  
Vol 45 (1-3) ◽  
pp. 187-193 ◽  
Author(s):  
Karen M. Van de Velde-Kossmann
Keyword(s):  
Renal Failure ◽  
Renal Disease ◽  
Genetic Disorders ◽  
The United States ◽  
Underlying Disease ◽  
Careful Examination ◽  
Common Skin ◽  
Important Diagnostic Tool ◽  
Stage Renal Disease ◽  
End Stage

Renal failure is common in the United States with an estimated prevalence of 660,000 treated end-stage renal disease patients in 2015 [<xref ref-type="bibr" rid="ref1">1</xref>]. Causes of renal failure are many, and complications from renal failure, underlying disease, and treatment are not infrequent. Examples of common skin manifestations include xerosis, pigmentary change, and nail dystrophies. Frequent disease-specific skin changes may be helpful in the diagnosis of primary disorders leading to renal disease or severity of disease including bullosis diabeticorum, sclerodactyly, or leukoctoclastic vasculitis. Some cutaneous changes, such as the multiple angiokeratomas of Fabry disease or the plexiform neurofibromas of neurofibromatosis, are pathognomonic of genetic disorders, which often lead to renal failure. Careful examination of the skin can provide crucial clues to diagnosis of renal failure causation and aid in monitoring complications.

scholarly journals Effect of Hypochromasia on Specific Gravity and Sedimentation of Red Cells

BMJ ◽  
1952 ◽  
Vol 1 (4768) ◽  
pp. 1109-1111 ◽  
Author(s):  
K. B. Rogers
Keyword(s):  
Specific Gravity ◽  
Red Cells

INDUSTRIAL ACTIVITY REVIEW OF THE FRENCH NETWORK OF PEDIATRIC CLINICAL INVESTIGATION CENTERS (FN-PCIC) 2008–2013

2015 ◽  
Vol 101 (1) ◽  
pp. e1.27-e1
Author(s):  
Elsa Maksooud ◽  
Evelyne Jacqz-Aigrain
Keyword(s):  
Clinical Trials ◽  
Clinical Investigation ◽  
European Medicines Agency ◽  
University Hospitals ◽  
European Regulation ◽  
Clinical Investigations ◽  
Number Of Patients ◽  
Inclusion Rate ◽  
The Impact ◽  
Drug Studies

IntroductionThe French Network of Pediatric Clinical Investigations Centers (FN-PCIC) created in 2000 includes today 16 CIC grouped under the auspices of the INSERM and the corresponding public university hospitals. In response to the European pediatric regulation published in 2007, all pharmaceuticals laboratories, in order to complete their drug profile, must conduct pediatric clinical trials according to the Pediatric Clinical Investigation Plan and validated by the European Medicines Agency (EMA). This network plays a major role in facilitating and optimizing the conduction of nation-wide pediatric clinical trials. Therefore, the PN-CIC plays a major role to response to this acute demand in the pediatric field. The purpose of this review is to sum up the activity of the FN-PCIC between 2008 and 2013 and to analyze the impact of the European regulation.MethodsOnly the industrial protocols will be analyzed, for every protocol a certain number of information was collected such as the pharmaceutical industry, the therapeutic fields, the phase of the study, the duration of the study, the methodology, and the number of patients needed.Results261 protocols were active during this period by 90 different sponsors. 218 were interventional studies and 43 were observational or non-drug studies (registers, post-AMM). The number of active studies was at 127 in 2013 compared to 76 in 2008. Furthermore, the total number of participations were 242 for 16 CIC in 2013 compared to 110 in 2008. The mean inclusion rate was 87%. The percentage of the common studies rises from 36% in 2008 to 50% in 2013. In addition, the feasibility study demands increased and were as high as 57, an average of one demand per week The inclusion percentage calculated using the data of the closed studies is at 87%. The therapeutic fields concerned were nephrology and oncology (15%), then neurology and pneumology (13%).ConclusionActivity increased, linked to the national coverage now including 16 centers and high quality procedures to perform pediatric research trials under high ethical and quality standards.

Physical Characteristics of Red Cells Collected from the Spleen

1971 ◽  
Vol 49 (12) ◽  
pp. 1092-1099 ◽  
Author(s):  
A. C. Groom ◽  
S. H. Song ◽  
P. Lim ◽  
B. Campling
Keyword(s):  
Bone Marrow ◽  
Specific Gravity ◽  
Ringer Solution ◽  
Red Cells ◽  
Venous Outflow ◽  
Morphological Studies ◽  
Arterial Blood ◽  
Free Cells ◽  
Vascular Channels ◽  
Kinetics Of

Kinetics of cell washout, when isolated cat spleens are perfused with Ringer solution, have shown previously that the red cells stored in the spleen correspond to a system of three compartments (fast, intermediate, and slow); morphological studies, at different stages of the washout, have already identified these compartments as free cells in vascular channels, free cells within sinuses, and cells adhering to sinus walls, respectively. By collecting the venous outflow at three particular stages of the washout fairly pure samples (>85%) of the cells from each compartment have now been obtained. We have measured the density (phthalate method), volume, and osmotic changes (Celloscope) of these cells. Cells from the fast and intermediate compartments were not significantly different from those of arterial blood, but cells from the slow compartment were lighter (specific gravity difference was 0.0064; p < 0.01), larger in volume (5.0%; p < 0.01), and swelled 14% less in 200 mOsmol/l (p < 0.01). These differences indicated that cells from the slow compartment might be predominantly younger cells and this has been confirmed by finding reticulocyte counts of 58.0 ± 3.8 (S.E.) %. It is suggested that immature red cells, released from the bone marrow, may be sequestered in the spleen and matured.

scholarly journals The Effect of repeated Bleedings on the Blood Constituents of Immunised Horses

1913 ◽  
Vol 13 (3) ◽  
pp. 353-368 ◽  
Author(s):  
R. A. O'Brien
Keyword(s):  
Mast Cells ◽  
Specific Gravity ◽  
Total Protein ◽  
Experimental Error ◽  
Mononuclear Cells ◽  
Red Cells ◽  
Differential Count ◽  
Blood Constituents ◽  
Sheep's Red Cells

(1) From a horse injected with sheep's red cells three months prior to the first bleeding and in a condition of constant haemolytic titre 122 litres of blood were taken in a period of 11 months. The horse's condition remained good throughout and has markedly improved during the year.(2) The net result was that the haemolytic titre during that time fell only to about 66% of its original value, the leucocytes to about 66%. haemoglobin scarcely at all, while the specific gravity of the blood and total protein have increased, the former by 10% the latter by 5%;.(3) There was no relationship between the total number of leucocytes and the amount of antibody. The differential count showed an increase of 12% in the polymorphonuclear and a decrease of 12% in the mononuclear cells, these figures being not very far outside the experimental error. The eosinophile and mast cells showed no marked alteration in number, size or staining reactions.

scholarly journals Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

2021 ◽  
Author(s):  
A G Fraser ◽  
R G H H Nelissen ◽  
P Kjærsgaard-Andersen ◽  
P Szymański ◽  
T Melvin ◽  
...  
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Real World ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
European Federation ◽  
The European Union ◽  
Clinical Investigations

Abstract In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent ‘conformity assessment’ organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details—which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe.

scholarly journals Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

2021 ◽  
Vol 6 (10) ◽  
pp. 839-849
Author(s):  
Alan G. Fraser ◽  
Rob G.H.H. Nelissen ◽  
Per Kjærsgaard-Andersen ◽  
Piotr Szymański ◽  
Tom Melvin ◽  
...  
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Real World ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
European Federation ◽  
The European Union ◽  
Clinical Investigations

In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity assessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details – which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE–MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081

Sign in / Sign up

Export Citation Format

Share Document