PLACE LABEL HERE
TRUE-AHF
INVESTIGATIONAL STUDY
ORDERS
The following orders will be implemented. Orders with a “q” are choices and are NOT implemented unless checked.
Initial all handwritten order modifications and the bottom of each page when indicated (multipage).
Date/Time of enrollment: ______Date/Time of infusion initiation: ______
1. Restricted medication to ED, ICU, 5N Cardiac telemetry unit as IMCU status.
2. Use vials # ______/______for admixture of bags 1 and 2.
3. Height: ______Weight in KG: ______
BP at Randomization: ______
4. Timed Labs: (Dates and times below to be determined by study team)
15 Minutes before infusion: CHEM 7
Date/Time:
NOTE: THIS SPECIMEN TO BE OBTAINED WITH STUDY TEAM PRESENT
48 Hours into infusion (+/- 30 min): CBC, CMP, CK, LDH, GGT
Date/Time:
NOTE: THIS SPECIMEN TO BE OBTAINED WITH STUDY TEAM PRESENT
72 Hours into infusion (+/- 60 min): CMP, CK, LDH, GGT
Date/Time:
5. Enter clinical study order in HEO
6. Investigational Medication
Pharmacy preparation:
· Withdraw 5 ml of sterile saline from a NS 250 ml bag and add to one study vial.
· Following reconstitution, the entire content of the vial is to be added to the original NS 250 ml bag. The total volume will be 250 ml.
· The right side label (tear off portion) should be attached to the infusion.
· Infusion is stable 24 hours after compounded.
· At 24 hours, mix another bag as above with the 2nd assigned vial #.
RN Administration:
· Begin infusion at rate of 0.09 ml/kg/hr (see TRUE-AHF Infusion nomogram on back) for 48 hour infusion.
· At 24 hours, document remaining investigational medication and return bag/tubing to pharmacy for destruction.
· Hang a new bag at this time to complete total 48 hour infusion.
· At the end of 48 hours, return bag/tubing to the pharmacy for destruction.
7. Call Dr. Pride (678-312-9100) and activate Hypotension prn orders (see next page) for any of the below:
· Symptomatic hypotension (dizziness, syncope, cold or clammy skin, altered mental status, fatigue, rapid shallow breathing, lethargy, or other new symtoms)
· SBP < 100 without hypotension symptoms
· SBP decline by > 40 mmHg from baseline at randomization
Copy to pharmacy Order writer’s initials ______
*4-37829* FORM 4-37829 INITIATED 10/2014 Page 1 of 3
PLACE LABEL HERE
TRUE-AHF
INVESTIGATIONAL STUDY
ORDERS
Reference Page
TRUE-AHF Infusion Nomogram for initial dosing
Patient Weight KG / Infusion rate 0.09 ml/kg/hr / Total volume in 24 hours / Remaining volume per bag / Patient Weight KG / Infusion rate 0.09 ml/kg/hr / Total volume in 24 hours / Remaining volume per bag48 kg / 4.3ml/hr / 104 ml / 146 ml / 83 kg / 7.47 ml/hr / 179 ml / 71 ml
49 kg / 4.4 ml/hr / 106 ml / 144 ml / 84 kg / 7.6 ml/hr / 181 ml / 69 ml
50 kg / 4.5 ml/hr / 108 ml / 142 ml / 85 kg / 7.6 ml/hr / 184 ml / 66 ml
51 kg / 4.6 ml/hr / 110 ml / 140 ml / 86 kg / 7.7 ml/hr / 186 ml / 64 ml
52 kg / 4.7 ml/hr / 112 ml / 138 ml / 87 kg / 7.8 ml/hr / 188 ml / 62 ml
53 kg / 4.8 ml/hr / 114 ml / 136 ml / 88 kg / 7.9 ml/hr / 190 ml / 60 ml
54 kg / 4.9 ml/hr / 117 ml / 133 ml / 89 kg / 8 ml/hr / 192 ml / 58 ml
55 kg / 4.9 ml/hr / 119 ml / 131 ml / 90 kg / 8.1 ml/hr / 194 ml / 56 ml
56 kg / 5 ml/hr / 121 ml / 129 ml / 91 kg / 8.2 ml/hr / 197 ml / 53 ml
57 kg / 5.1 ml/hr / 123 ml / 127 ml / 92 kg / 8.3 ml/hr / 199 ml / 51 ml
58 kg / 5.2 ml/hr / 125 ml / 125 ml / 93 kg / 8.4 ml/hr / 201 ml / 49 ml
59 kg / 5.3 ml/hr / 127 ml / 123 ml / 94 kg / 8.5 ml/hr / 203 ml / 47 ml
60 kg / 5.4 ml/hr / 130 ml / 120 ml / 95 kg / 8.5 ml/hr / 205 ml / 45 ml
61 kg / 5.5 ml/hr / 132 ml / 118 ml / 96 kg / 8.6 ml/hr / 207 ml / 43 ml
62 kg / 5.6 ml/hr / 134 ml / 116 ml / 97 kg / 8.7 ml/hr / 210 ml / 40 ml
63 kg / 5.7 ml/hr / 136 ml / 114 ml / 98 kg / 8.8 ml/hr / 212 ml / 38 ml
64 kg / 5.8 ml/hr / 138 ml / 112 ml / 99 kg / 8.9 ml/hr / 214 ml / 36 ml
65 kg / 5.8 ml/hr / 140 ml / 110 ml / 100 kg / 9 ml/hr / 216 ml / 34 ml
66 kg / 5.9 ml/hr / 143 ml / 107 ml / 101 kg / 9.1 ml/hr / 218 ml / 32 ml
67 kg / 6 ml/hr / 145 ml / 105 ml / 102 kg / 9.2 ml/hr / 220 ml / 30 ml
68 kg / 6.1 ml/hr / 147 ml / 103 ml / 103 kg / 9.3 ml/hr / 222 ml / 28 ml
69 kg / 6.2 ml/hr / 149 ml / 101 ml / 104 kg / 9.4 ml/hr / 225 ml / 25 ml
70 kg / 6.3 ml/hr / 151 ml / 99 ml / 105 kg / 9.5 ml/hr / 227 ml / 23 ml
71 kg / 6.4 ml/hr / 153 ml / 97 ml / 106 kg / 9.5 ml/hr / 229 ml / 21 ml
72 kg / 6.5 ml/hr / 156 ml / 94 ml / 107 kg / 9.6 ml/hr / 231 ml / 19 ml
73 kg / 6.6 ml/hr / 158 ml / 92 ml / 108 kg / 9.7 ml/hr / 233 ml / 17 ml
74 kg / 6.7 ml/hr / 160 ml / 90 ml / 109 kg / 9.8 ml/hr / 235 ml / 15 ml
75 kg / 6.7 ml/hr / 162 ml / 88 ml / 110 kg / 9.9 ml/hr / 238 ml / 12 ml
76 kg / 6.8 ml/hr / 164 ml / 86 ml / 111 kg / 9.9 ml/hr / 240 ml / 10 ml
77 kg / 6.9 ml/hr / 166 ml / 84 ml / 112 kg / 10.1 ml/hr / 242 ml / 8 ml
78 kg / 7 ml/hr / 168 ml / 82 ml / 113 kg / 10.2 ml/hr / 244 ml / 6 ml
79 kg / 7.1 ml/hr / 171 ml / 79 ml / 114 kg / 10.3 ml/hr / 246 ml / 4 ml
80 kg / 7.2 ml/hr / 173 ml / 77 ml / 115 kg / 10.4 ml/hr / 248 ml / 2 ml
81 kg / 7.3 ml/hr / 175 ml / 75 ml / Max dosing based on 115 kg
82 kg / 7.4 ml/hr / 177 ml / 73 ml
REFERENCE PAGE
FORM 4-37829 INITIATED 10/2014 Page 2 of 3
PLACE LABEL HERE
TRUE-AHF
INVESTIGATIONAL STUDY
ORDERS
The following orders will be implemented. Orders with a “q” are choices and are NOT implemented unless checked.
Initial all handwritten order modifications and the bottom of each page when indicated (multipage).
Hypotension PRN Orders
Clinical symptoms of Hypotension:
Dizziness, syncope, cold or clammy skin, altered mental status, fatigue,
rapid shallow breathing, lethargy, or other new symptoms
A). Hypotension WITH symptoms:
1. Review MAR with study physician and discontinue drugs with hypotensive effect according to physician’s orders.
2. Temporarily discontinue study drug:
3. Monitor BP for at least 2 hours (Every 15 minutes x 1 hour, then every 30 minutes x 1 hour)
4. After 2 hours of temporal discontinuation, if:
· SBP is ≥ 116 mmhg,
AND
· No symptoms of hypotension during the last 2 hrs since discontinuation of study drug
Perform a single attempt to restore study drug infusion at 50%, monitor BP q 15 mins x 1 hour.
5. If symptomatic hypotension recurs OR SBP decreases to < 100 mmhg, STOP DRUG PERMANENTLY
B). Hypotension (SBP < 100) WITHOUT symptoms:
1. Review MAR with study physician and discontinue drugs with hypotensive effect according to physician’s orders.
2. Reduce study drug by 50%
3. Monitor BP for at least 30 minutes (Every 15 minutes x 1 hour, then every 30 mins x 1 hour)
4. If the SBP is < 100 mmHg following dose reduction, temporarily discontinue the drug.
5. Continue monitoring BP for at least 2 hours
6. After 2 hours of temporal discontinuation, if:
· SBP is ≥ 116mmHg,
AND
· No symptoms of hypotension during the last 2 hrs since discontinuation of study drug
Perform a single attempt to restore study drug infusion at 50%, monitor BP q 15 mins x 1 hour.
7. If SBP decreases again to < 100 mmHg STOP DRUG PERMANENTLY
C). SBP declines by > 40 mmHg from baseline following randomization without clinical symptoms:
1. Review MAR with study physician and discontinue drugs with hypotensive effects according to physician’s orders.
2. Reduce study drug by 50% for the remainder of the study.
______
Date Time Physician Signature PID Number
Copy to pharmacy
FORM 4-37829 INITIATED 10/2014 Page 3 of 3