Supplemental Agreement - Contract No. at-(40-1)-233, Tulane University, Modification No. 3 (Redacted)

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of March 19153, effective as o f IsbruPry 6, 1953, and WHE?&S, the Oovarnment and the Contractor ' entered into Cantract B o * O-(h0-1)-233, dated February 6, 1950, for the performance bp the Contractor of a research project Frivol-g a stuw of the turnover rate of chlorfne under controlled dietkry therapeutic condftiats Fn patient sri th congestive heart fail urn and in control subjects; and w,t h e contract has be= mended heretofore by Yo&%- -, the parties des irt to art end the term a i the contract in ' or wr to continue the study 85 here in lddicated; and XHERUS, this Snpplemsntd Agreement is authorized rhd executed under tne Atomic Ehsrgv Act of 19L6; in the fol ld - n gp afi icu lars, but in no others : 1. Add the follorrlng new subsection 6. t o Sectior 2 of ad. ' he wy kin the fourth period, in addition to fur the study of data here to for so cm late d, rill consist of cont bu ed study of the tu-nowr rates of chlorine, potassitm, soolae, rubidium and cesium under controlled diet L7 and therapeutic conditions inpatients d th congestive hee-t failure and i n

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"me fourth period o f performance uill commence on Feb h arg 6, 1953, and rill end on Febrvary 5 , 19a.m . nd. I n consideration of the performance of the work described inn tle IT of Appen& 'A', the Government rill pay tothe Contractor the sum of Sh.Thousand Pins kn dred Fifty Dollar8 ($6,950.00) for the fourth period of perform8nce.n ~ ORTZ SAND INSPETICIR: a&. Examination of Records. a. The Contractor agrees that the Comptroller Cknsral of the United States or8.u ~of his duly anthorfzed representatiVf38shall, until the expiration of three years Cter fhal payment under this contract, have access t o and the fi@t t o examine my directly pertinent books, documen&, pgPem d records of the Contractor involving transactions related to b. B e Contractor further agrees t o include in all his subcontracts hereunder a provision to the effect that the subcontractor agrees that the ' Comptroller General of the United States or any of hi8 duly authorized representatives shall, until the emirati on of three years after ZFnal pgylnent under this contract ri th the Government, have access t o and the right to exmine aqy directly pertinent books, documents, papers, and records of such sab contractor involving trans - actions related to the subcontract. b e term subcontract 88 used here ln does not include (i)purchase orders not exceeding $503, o r (fi) contracts or purchase orders for publlc ut'ility services at rates established for uniform applicability t o C. Nothing In this contracts hall be deemed t o preclude an audit by the General Accounting Office of any transaction under this contract.

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5 . Add the fol ld ng new TITLE IV t o Appendix WAS: na. Present Status nRperiments with C1s and Rba6 on man 85 a whole RIM chronic congestive heart faaure and i n control .subjects are continuing. To a ate the bio logic half- .life and the rapid disappe race rates of the isotope ' from t h e 86plasma and of Bb from whole blood and erythrocytes have been determined. rates have been calculated. From the xperiments it has been shorn that ax, Rb86 sad Haz3 exchange among several compartments In the bow, the rates of exchange varyj.n.5 from time tothe. .Studies on the transfer of these isotopes into and out of e ry thro cp tes in vitro have progressed satis facto m. Some of the data have been submitted f o r publication and others are being prepared for publication. Experiments are i n progress i n do S rrith the use of E& alone and sbultzkeously uith 11&2 to learn the transfer rates into the ha& muscle of the dog as well as other DSI$UI~ and also to detelmine further the adequacy of RbB6 as "b. Scme and Plan of Approach "It is planned to continue the observations of the inter - com par bent al exchange of Ha22, RbB6, and including a study of blister surfaces proaucad on the forearm ul th can th a rides plaster and isolated by plaster compartmental exchange phenomem across a membrane man which is readily acce86ib18. fl*l1be employed in normal and abnonnal states. BUDGIE - Fourth Period: Tne small, fairly Worm isolated com?artaents produced Xi11 pennit observation of these "a. me Contractor rrill furnish as its contribution t o

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(1) Salaries of staff members,including the Project Leader, and other personnel engaged Fn the work i n axceB8 of the Gove ment ' s cont rih tion under b. belon. (2) Use of laboratory work space; and equipment, materials, and supplies needed for the project in exces8 of the Oovsrment I s payment under b. belor. .b. The Government dn pzy to the Contractor t h e sum of Six Thousand N l n e Eundred FFTty Dollars ($6,950.00) which All clerical, a-trative and overhead coats . rLll cover the Contractor ' s other expenses, estimated as . follows, in the per f ow ce of the contract bring the (1) Salaries and Wapss Remaining from al rd period so .00 WC. Items of property procured o r manufactured by the Contractor, title to which will vest in the Goverwent (see b tic le VI): Bone.. 6. Delete the fourth sentence of paragraph a., Section 3 - fol lo ring :

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Contractor agree8 t h a t It rill not pernrit any bu vi wd to have access to restricted data until the designated investigating qenw shall have made an investigation ad report to the COdS siOn On the character, associatiom, und loyalty of such in uv i dud and the Conscission shall have osterdried that permitting such pereon to have acces8 to restricted data dll not endanger the common defense or security. As used In the paragraph the term 'designated investigating agency' means the United States Civil Se-ce Coucission or the Fed era Burem of Investigation,or both, as determined pursuant to the provisions of the Atomic kern Act of 19L6, aa amended by the mem tal Agreement the day and year first above url tb n. THE UNITED STATB OF AH5UCA TITUS2 Research & He dic ge Mvlsion ACCEPTANCE BY PROJECT LEAD= I have read the foregoing Supplemental eee ment and agree to be bound by its terms.

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%. The work in tnc third period, in add it ianto coLtinu3d study of & it a a ccm slats d LP the seconc period, will cozis:: oif a study of ths turnmsr rstas of pot.assium, ru oid i - mad cesium der cort r ol is d dietary LA tSer&peu:ic cond it io = in patients Ritn cocgsstive heart fai ici ie and in control rubj-tr, pd

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2. Add th of oll on q nmr Sect i or2to ART ICE 11 - TEBY OF February 6, 1952, a n d will and on Fakruary 5, 1955.. "c. I n consideration of the performtune of the mrk pay tothe contractor the sum of Ens Thousand O m ffundrmd Eights Dol+ors ($9,160.00) for the th k d period of per - 4. Add the f oll ming xmw TITLE I11 t o dppendir " A n ; Pe bru cy 6, 1362 - February 5 , 1955n Four h w experiments bare been conducted over a siz - wesk period of continuou8 observance, during whioh time the dietarp in take of sodium, chlorine and potassiam rras known. The win9 and feces were collected separately a a passed, end blood s=zples were collected each morfor deter d nations of sodi ~ l l ~ ,potessium, cn lori de and RbB6 in the wine, xnoie blood and er yi boc v tes. Tne specinens of feces m restudied only for XbB6. tioas w e r e conaucted as tro 8eparate sxperiments, one a6 e pilot study on B conzrol subjsst, and r;notbr consisting 0," einubtclleou~o bse mt ions 03 a control subject and two pst i ents with chronic congestive hart failure. The data from these sxperixscts ail1 be exd ned critically nat only t o learn the turnover rate of Cs 134 and Rb8$ but a leo to SCOPO and Plu of B p ~ oech The data collected from these experiments dll be studied and x u experiments Vi11 be conducted usi e*iltsneously WLth 2586 and the contain sting C ez, thus

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pcrr > ttin ; 8 tracing of all thee simultaneously. and 2585 will be inject et simultaneously in order to trace tne elelrents immetkately and for several hours t o 8to deter aim more In addition ozperirnents ri:l be continued to t rao a BbB6 simultaneously rith detOnILiPatiOn8 of or dir ary potassiuzi, chl mia e and sodiron in red cells and fn the therms1 awe&% of acroes blister surfaces of 8kFn Of mn, blisters being made with cantharides planters, while 8jmu~tanaous obbervations are ads 02 the &, L, and C1 concentrations in the Mi at or fluid a n d blood 88- urn, Studies rill a l s o be made of diffusion of Rbe6 and Eez2 "a. The Cantractor Kill furnish 88its contribution tothe (1) S a lui es of staff members, inch ding the Ro J ect isader, and other personnel eagaged in the work i n excess of the OOvernment'a coot rib ~ i munder b. belar, ( 2 ) Use of laboratory work space; e n d equiprpsnt, praterials, and supplies needad rDr the project in exceaa of the (3) All cleric el,add de tr at ive and overhead costs in excess of the cOvBrnme3t's p y = ntder b. beloa. Rb. The Government will pey t o the Contractor theam of Eke Thousand Gre Bud red Bighty hll - 6 ($9,180.00) which rill tns perf5-3n~nce of the oontract during t ne third period: (1) Salariea and kg es alreatjy trained, t o be employed. during the course of metabolic

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( TUL ane University) between the UTUTE;D SThTE;S OF ILMEPJCA (han f nder called the nGovernnent"), represented here in by the UNITED STATES ATOtIIC ENERGY , 1951, effective as of February 6, 199-G and K'HERLVS, the Oo vc ment and the Contractor entered btC ont tract No, AT-(b&1)-233 on FebruaTy 6 , 19S, for t h e performance by the Contractor of a research project -volvFng aStUa of the tu,rnover rate of ahl or be under con-zoned die- and thtrapeutie conditions In patients riith congestive nee &lure and in control %WEAS, the partties here to aesfre to cxtend the term of the contract in order t o contlnue a d extend the research pmjeFt rnak3,x.g a related study of the turnover r8hS of chlorine and xubidium under controlled dietary and tnerapeutic conditions in patients d th mr onic congestive hevt failure a::in control subjects, as ciesd'bed bVA%AS, this Sup?lernmtd Agreenent I s authorized z ~ d X'OY;, TH;P,3.?ORE, t h e parties hereto do mtzL&y agree that executed user the A to bc Energy Act of 1916; 1- Ada the folhrping nen subsection bto Section 2 of SUJ@ of the turnover ra*tsE of chlorine ana ru bidi un under controlled riietary and therapeutic conditions in patients xith chronic congestive heart fe lure and in control subjects, a8 described in Title XI of A?pendix Thc work in the second period shU consist of a

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-n z 0 The second period of ?eerforrYace fort ne project covered ~y this contract K i l l comnence on February 6, 1951, and rill end on February 5 , 1952." Add the following subsection bto Section 1 ofc--- "be In consideration of the 2erforsance of the uork described in Title 11 of AFpendix ' A ! tne Government trill pay tothe Contractor the sun of Nhe Thousand &, Add the fol lod ng new Title II to Appendix "An: "The biologic decav rates of sodium and mercury, with tne use of Na2* and Hg2*3, have been measured for n0rJE.d man, for patients xith chronic congestive heart failure ana for patients with the nephrotic uore recent b, after coropletion of studies of the bi logic decay rates for the 'long-life radiochloride, was granted by the Abmic mer= Commission for hum= experiments, Accordingly, adf ici ent o r 50 uc) in water to6 adult female subjects -2 controls and L patients nith chronic congestive heart failure, two mild and two severec Tnus it has been possible for the first the to measure directly the bio logic decay rates of chlori6e in nod r;ul and in a subject with a disturbance in aottr and electrolyte balance, chronic heart failure, The mcjrtanca of these rates o f turnover i n cardiov?scular adjustment to human physiologic

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'lhe id hence of chloride in take in the bet u3on these bioiocic aecay rates of chloride IT=measured- l n e influence of ha, K, rrilkr, bicarbmate, bronlde, cortisone, and o'her chloride was also dat c nine d,jemn ed # urine sodiu~n, potassium, and chLor3.de as well. Variations in tn echl ori or co part ra tnt of man and the k influence on the a foreman tio ned - . : factors and variables were recorded. The apS to .iay vaz i a tian s In chloride apace .LS well aa of seasuring chloride coq utm ents were Now that infomation is avzilabls on the - bio logic dealy raLes af sodiu10, merc ~ r pa d chlo ria e for nod man and for pot i ents xith ell Poproach the bio logic decay periods of seek'to thron light upon the accuracy with rrhich this is g to pe traces pot as i um, Permission has already been obtaintd.fmm the Subcomdttee on Human AppLications to study man rrith radionabidium for the first t be, It is the opinian of rwst physiologists and cneroists that rubic!ium tends t o follow potassium Fn its lretaiwUc befravior, 21Lhough recently it has been suggeskd interested In stu a ying the turnover of pot39sium in t h e body of nar;nal man and of patieats Kith cangestive heart fal ur r, but KL2 has such P short obsemation, Radiorubidium might be used far such I pztients uith congestive heart failure and observe f;;ilure or edezz. During t h e . course of these oj servo t ions under conditions for metabolic study, controlled, the output uill be measured, adthe

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*a. me Contractor rdll furnish m its contrlbution (1) ii ah ries of etaff mezbers, includFpg the F'roject >&der, waged in the work, except aa provided in b (1) belm, (3)Qe rita l and &d.nbstrativs arpanser and in excess af the overhead rlluuanco provided "b. The b ve ment to the Contractor the sum o'her expenses eat hated as fo'llolra, hthe perfonnzncs of the wntract during t h e second O f Nine Thousand uric ffurdred a&tJ'm332rS

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ke clc l ne, Cardiovtiscular Research Laboratory Scope nnd Present Status c intra vs nou6 injection into humin subjects to oatermine t …