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Section 6 - Gp 11 - Pharma Journal
Transcript of Section 6 - Gp 11 - Pharma Journal
Chronic Kidney Disease
What is CKD?
Chronic Kidney Disease is a disease that occurs when one suffers from gradual and usually permanent loss of kidney function over time
Protien in urine
We'll focus on..
No off-pump CABG..
Nihon University Itabashi Hospital
The purpose of this comparative study is to prove the efficacy of the human atrial natriuretic peptide (hANP) in patients with chronic kidney disease (CKD) undergoing coronary artery bypass graft surgery (CABG).
This was a randomized controlled study of 303 patients with CKD who underwent CABG, and were divided into a group who received carperitide infusion and another group without carperitide (placebo group).
The study was double-blinded, placebo-controlled, parellel and randomized by lottery method.
The primary endpoints were:
1) the post-operative dialysis-free rate.
2) serum creatinine (sCr) and estimated glomerular filtration rate (eGFR).
The secondary endpoints were:
1) the early post-operative outcome.
2) outcome at 1 year post-operatively.
3) the maximum sCr, the rate of increase of sCr, and an increase of sCr by 0.3 mg/dl compared with the pre-operative value.
4) ANP and cyclic-guanosine monophosphate levels.
1- Non dialysis CKD. 2-Undergoing On-pump CABG.
Dialysis. Cardiogenic shock. Off-pump CABG.
post-operative sCr was significantly lower
in the hANP group not only in the post-operative acute stage but also in the first year. The
maximum Cr and Cr increase rate were significantly lower
in the hANP group (p 0.00665, p 0.0001).
There was no difference in mortality rate in the first year post-operatively, and fewer cardiac events and patients going on dialysis were found in the hANP group (p 0.0001 and p 0.0014, respectively).
The paper was published in:
American College of Cardiology.
Reliable & significant statistical results.
Highly relevant to references.
Appropriate study design (Selection, randomization, primary and secondary end points and minimum inclusion criteria).
Clear objectives, aim and informative background.
Unbiased discussion and conclusions and reasoning by results of similar trials.
Funding is by grant from three NGOs.
assessed e.g, AST,CK,hs-CRP,TAG & LDL, tropnin, myoglobim, LDH.
Although cGMP & ANP were assessed but they are
neither tabulated nor plotted
Mode of action of cGMP isn't mentioned
& what's its relation to hANP in our study ?
We found 2 points of confections:
"In the present study, carperitide or saline administration was discontinued only when the systolic blood pressure could not be maintained at 90 mm Hg using intra-aortic balloon pump."
"......and administration was not discontinued for reasons such as hypotension in any of the patients."
eGFR results show significant decrease in hANP gp but he said:"the hANP group showed significantly lower values than the placebo group (p 0.01)."
Method of measurment : not mentioned in all biomarkers (just eGFR & delta % sCr )
Confounding factors are not mentioned (e.g., life style, medical history, other treatment, etc..).
Facilities at site of performance aren't mentioned in this paper.