"Clinical Centers for the Clinical Network for the Treatment of the Adult Respiratory Distress Syndrome (ARDS)"

Amendment No.:	Two (2)
Amendment Date:	April 12, 2000
RFP No.:	NIH-NHLBI-HR-01-01
RFP Issue Date:	March 17, 2000
Issued By:	Pamela S. Lew, Contracting Officer NIH, National Heart, Lung, and Blood Institute HLVD Contracts Section, Contracts Operations Branch 6701 Rockledge Drive, Room 6104 Bethesda, MD 20892-7902
Names and Addresses of Offeror(s):	To all interested recipients of RFP NIH-NHLBI-HR-01-01

1. Section I, Technical Information, Part 1, Statement of Work - Phase II is amended to correct the 3rd paragraph to read in part "Enroll and treat a minimum of 30 patients per year, ..."

2. Section II, Specific RFP Instructions and Provisions, subparagraph h. Estimate of Effort, should have indicated that the levels of efforts for Phase II, as shown in the table, are yearly levels. The "Total" column is deleted in its entirety.

3. The PAC Protocol (Version I) dated March 16, 2000, which is part of the RFP, is amended as follows as of April 11, 2000:
   1. Study Summary - Inclusion Criteria, #13 is amended to read "Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be equal to or greater than 50%."

   2. Study Summary - Exclusion Criteria, #12 is amended to read "Morbid obesity (> 1 kg/cm body weight)."

   3. Study Summary - Exclusion Criteria, #16 is added to read "Renal failure requiring renal replacement therapy."

   4. Study Summary - Exclusion Criteria, #17 is added to read "Severe, chronic liver disease (Child-Pugh Score of 10-15)."

   5. Section V, Exclusion Criteria, #12 is amended to read "Morbid obesity (> 1 kg/cm body weight)."

   6. Section V, Exclusion Criteria, #13 is amended to read "Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be equal to or greater than 50%."

   7. Section V, Exclusion Criteria, #16 is added to read "Renal failure requiring renal replacement therapy."

   8. Section V, Exclusion Criteria, #17 is added to read "Severe, chronic liver disease (Child-Pugh Score of 10-15).

      Liver Failure: Child-Pugh Class C, which is defined as a total of 10-15 points on the following scoring table:

      Points	Class
      5-6	A
      7-9	B
      10 or more	C

      	Numerical score for increasing abnormality
      Measurement	1	2	3
      Ascites	None	Present	Tense
      Encephalopathy	None	Grade I or II	Grade III or IV
      Bilirubin (mg/dL)	< 2	2-3	> 3
      Albumin (g/L)	> 35	28-35	< 28
      Prothrombin time (sec. Prolonged)	1-4	4-10	> 10

      "

   9. Section VIII. Procedures - Assessments During Study, #14.c is amended to read "Worst creatinine, bilirubin, and platelet count for that date."

   10. Appendix II, Part 2.3, Assessment for Tolerance, is amended to correct the last paragraph to read "If any of goals 1-3 are not met on initial PS, then the ventilator mode will be changed back to A/C at back-up rate = to most recent A/C settings and the patient will be reassessed the next morning."

   11. Appendix II, subpart 2.4.2 is amended to delete the text contained within the parentheses ( ).

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