Trial Outcomes & Findings for FAST PV and mGFR™ Technology in Congestive Heart Failure (NCT NCT03808948)
NCT ID: NCT03808948
Last Updated: 2021-11-17
Results Overview
The percentage of treatment emergent SAEs considered to be surely related to the VFI should be zero.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
30 days
Results posted on
2021-11-17
Participant Flow
A totally of 50 hospitalized patients were enrolled between January 10th, 2019 and August 15th, 2019.
No patients were excluded after enrollment but before assignment to the treatment group.
Participant milestones
| Measure |
All Patients
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FAST PV and mGFR™ Technology in Congestive Heart Failure
Baseline characteristics by cohort
| Measure |
All Patients
n=50 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 13.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
50 participants
n=5 Participants
|
|
Weight day 1 (kg)
|
89.21 kilograms
STANDARD_DEVIATION 22.24 • n=5 Participants
|
|
Height day 1 (cm)
|
172.84 Centimeters
STANDARD_DEVIATION 10.62 • n=5 Participants
|
|
BMI day 1 (kg/m2)
|
29.7 Kilograms / meter squared
STANDARD_DEVIATION 6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe percentage of treatment emergent SAEs considered to be surely related to the VFI should be zero.
Outcome measures
| Measure |
All Patients
n=50 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Number of Participants With Treatment Related AEs and Serious Adverse Events (SAEs)
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 daysFunction of the FAST PV measurement will be assessed by determining the plasma stability of the FD003 high molecular weight marker over the 15, 30, and 60 minute blood draws and applying the following criteria: * The FAST PV measurement is considered as stable, if the mean plasma concentration of FD003 at 30 minutes is not more than 10% lower than the mean plasma concentration at 15 minutes AND if the mean plasma concentration at 60 minutes is not more than 10% lower than the mean plasma concentration at 30 minutes * We will determine the percentage of patients which show a decline in the plasma concentration of FD003 of more than 10% from 15min to 30min and separately from 30 min to 60min. This percentage should be ideally close to 0.
Outcome measures
| Measure |
All Patients
n=50 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Percentage Difference in Mean Plasma Concentration of FD003 Over the 15-, 30-, and 60-minute Blood Draws on Days 1 and 3
Difference between Day 1 mean plasma concentration of FD003 at 15 minutes and 30 minutes
|
-2.36 Percent difference, plasma concentration
Standard Deviation 7.94
|
|
Percentage Difference in Mean Plasma Concentration of FD003 Over the 15-, 30-, and 60-minute Blood Draws on Days 1 and 3
Difference between Day 3 mean plasma concentration of FD003 at 15 minutes and 30 minutes
|
-3.12 Percent difference, plasma concentration
Standard Deviation 11.29
|
|
Percentage Difference in Mean Plasma Concentration of FD003 Over the 15-, 30-, and 60-minute Blood Draws on Days 1 and 3
% difference between Day 1 mean plasma concentration of FD003 at 30 minutes and 60 minutes
|
-0.8 Percent difference, plasma concentration
Standard Deviation 5.6
|
|
Percentage Difference in Mean Plasma Concentration of FD003 Over the 15-, 30-, and 60-minute Blood Draws on Days 1 and 3
% difference between Day 3 mean plasma concentration of FD003 at 30 minutes and 60 minutes
|
-0.79 Percent difference, plasma concentration
Standard Deviation 8.67
|
SECONDARY outcome
Timeframe: 3 daysPopulation: One patient did not have a hematocrit available for ePV determination, fourteen patients did not have day 3 measurements of mPV.
The percentage difference between ePV and mPV were evaluated to consider the percentage of the population with a \<15% and \<30% difference between ePV and mPV on day 1 and day 3
Outcome measures
| Measure |
All Patients
n=49 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Accuracy Between Estimated PV (ePV) on Days 1 and 3 (by Established Measures) and Measured PV (mPV; as Assessed by FAST Methodology) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number patients where ePV (Kaplan Hakim) was within 15% of mPV day1
|
32 Participants
|
|
Accuracy Between Estimated PV (ePV) on Days 1 and 3 (by Established Measures) and Measured PV (mPV; as Assessed by FAST Methodology) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number patients where ePV (Kaplan Hakim) was within 30% of mPV day 1
|
44 Participants
|
|
Accuracy Between Estimated PV (ePV) on Days 1 and 3 (by Established Measures) and Measured PV (mPV; as Assessed by FAST Methodology) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number patients where ePV (Kaplan Hakim) was within 15% of mPV day3
|
24 Participants
|
|
Accuracy Between Estimated PV (ePV) on Days 1 and 3 (by Established Measures) and Measured PV (mPV; as Assessed by FAST Methodology) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number patients where ePV (Kaplan Hakim) was within 30% of mPV day3
|
30 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: One patient did not have a hematocrit on day 1 for calculation of mTBV and eTBV, twelve patients did not receive a second measurement on day 3, two patients that recieved a second measurement, did not have a hematocrit on day 3 for calculation of mTBV and eTBV
Accuracy between the Nadler's Formula as an estimate of total blood volume (TBV) and measured blood volume (mTBV) on days 1 and 3 as determined by the percentage of the population with a \<15% and \<30% difference between ePV and mPV
Outcome measures
| Measure |
All Patients
n=49 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Accuracy Between Estimated Total Blood Volume (TBV) on Days 1 and 3 and Measured TBV (mTBV; Calculated From mPV and Measured Hematocrit) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number of patients where eTBV was within 15% of mTBV value day1
|
32 Participants
|
|
Accuracy Between Estimated Total Blood Volume (TBV) on Days 1 and 3 and Measured TBV (mTBV; Calculated From mPV and Measured Hematocrit) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number of patients where eTBV was within 30% of mTBV value day1
|
45 Participants
|
|
Accuracy Between Estimated Total Blood Volume (TBV) on Days 1 and 3 and Measured TBV (mTBV; Calculated From mPV and Measured Hematocrit) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number of patients where eTBV was within 15% of mTBV value day3
|
25 Participants
|
|
Accuracy Between Estimated Total Blood Volume (TBV) on Days 1 and 3 and Measured TBV (mTBV; Calculated From mPV and Measured Hematocrit) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Number of patients where eTBV was within 30% of mTBV value day3
|
32 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: twelve patients did not have mGFR measurement on day 3, so only 38 patients are analyzed on day 3
To evaluate whether estimated Glomerular Filtration Rate (eGFR) (calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) on days 1 and 3 provides an accurate estimate of measured GFR (mGFR; assessed by FAST methodology) in heart failure patients under-going active fluid management, determined by the percentage of patients with a \<15% and \<30% difference between eGFR and mGFR
Outcome measures
| Measure |
All Patients
n=50 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Accuracy of eGFR Determined by CKD-EPI-SCr and mGFR on Day 1 and Day 3 Defined the Percentage of the Population With a <15% and <30% Difference Between eGFR and mGFR
Number of patients where eGFR was within 15% of mGFR value on Day 1.
|
20 Participants
|
|
Accuracy of eGFR Determined by CKD-EPI-SCr and mGFR on Day 1 and Day 3 Defined the Percentage of the Population With a <15% and <30% Difference Between eGFR and mGFR
Number of patients where eGFR was within 15% of mGFR value on Day 3.
|
10 Participants
|
|
Accuracy of eGFR Determined by CKD-EPI-SCr and mGFR on Day 1 and Day 3 Defined the Percentage of the Population With a <15% and <30% Difference Between eGFR and mGFR
Number of patients where eGFR was within 30% of mGFR value on Day 1.
|
33 Participants
|
|
Accuracy of eGFR Determined by CKD-EPI-SCr and mGFR on Day 1 and Day 3 Defined the Percentage of the Population With a <15% and <30% Difference Between eGFR and mGFR
Number of patients where eGFR was within 30% of mGFR value on Day 3.
|
24 Participants
|
SECONDARY outcome
Timeframe: 48-72hPopulation: 36 patients had data for AKI determination 48h after day 1, 32 patients had data for AKI determination after day 3
To evaluate the percentage of patients developing acute kidney injury (AKI) within the following 48-72 hours on day 1 and day 3 and to evaluate whether patients with a low mGFR/eGFR ratio on days 1 and 3 are at higher risk of developing acute kidney injury (AKI) within the following 48-72 hours using a binary logisitic regression with AKI as binary outcome and mGFR/eGFR as independent variate
Outcome measures
| Measure |
All Patients
n=36 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Percentage of the Population That Developed Acute Kidney Injury (AKI) Within the Following 48-72 Hour and Prediction of AKI by mGFR/eGFR Ratio on Days 1 and 3
Number of patients with AKI within 48h after day 1
|
17 Participants
|
|
Percentage of the Population That Developed Acute Kidney Injury (AKI) Within the Following 48-72 Hour and Prediction of AKI by mGFR/eGFR Ratio on Days 1 and 3
Number of patients with AKI within 48h after day 3
|
11 Participants
|
SECONDARY outcome
Timeframe: 5 daysPopulation: one patient did not have weight data, two patients were discharged after first measurement (day 1) so no lineary observation was possible
Being refractory to diuretic therapy (defined as any dosage increases of furosemide i.v. dose equivalent, adding thiazide after day 1, requirement of ultrafiltration/RRT within the next 24-48 hours, failure to improve subjectively in PGA and dyspnoea scales, failure of mean weight loss during the study period Day 1-Day 5 of at least 0,5 kg/d).
Outcome measures
| Measure |
All Patients
n=47 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Percentage of Patients Who Are Refractory to Diuretic Therapy
Not refractory to diuretics
|
7 Participants
|
|
Percentage of Patients Who Are Refractory to Diuretic Therapy
Refractory to diuretics
|
40 Participants
|
SECONDARY outcome
Timeframe: 3 daysPercentage of patients for whom the data decision committee decided to increase or decrease the dose of diuretics, guideline-directed medical therapy (GDMT), beta-blockers, or RAAS inhibitors from the dose indicated by the treating physician after considering the mPV/mTBV determined using FAST BioMedical technology.
Outcome measures
| Measure |
All Patients
n=50 Participants
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Percentage of Population in Which Clinical Decision Making Would Have Been Influenced by Adding FAST GFR and PV Measurements to Clinical Routine Determined by Survey Response (by an Adjudication Committee)
Number or patients where adjudication committee would have changed diuretic dose
|
40 Participants
|
|
Percentage of Population in Which Clinical Decision Making Would Have Been Influenced by Adding FAST GFR and PV Measurements to Clinical Routine Determined by Survey Response (by an Adjudication Committee)
Number or patients where adjudication committee would have changed RAASi dose
|
5 Participants
|
|
Percentage of Population in Which Clinical Decision Making Would Have Been Influenced by Adding FAST GFR and PV Measurements to Clinical Routine Determined by Survey Response (by an Adjudication Committee)
Number or patients where adjudication committee would have changed beta blocker dose
|
6 Participants
|
|
Percentage of Population in Which Clinical Decision Making Would Have Been Influenced by Adding FAST GFR and PV Measurements to Clinical Routine Determined by Survey Response (by an Adjudication Committee)
Number or patients where adjudication committee would have changed GDMT
|
1 Participants
|
Adverse Events
All Patients
Serious events: 21 serious events
Other events: 37 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
All Patients
n=50 participants at risk
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Infections and infestations
Pneumonia
|
6.0%
3/50 • 30 days
|
|
Infections and infestations
Endocarditis
|
4.0%
2/50 • 30 days
|
|
Infections and infestations
Infectious pleural effusion
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Urosepsis
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
2.0%
1/50 • 30 days
|
|
Cardiac disorders
cardiac failure
|
6.0%
3/50 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • 30 days
|
|
Renal and urinary disorders
Acute kidney Injury
|
6.0%
3/50 • 30 days
|
|
Renal and urinary disorders
Azotaemia
|
2.0%
1/50 • 30 days
|
|
Nervous system disorders
Cerebral infarction
|
2.0%
1/50 • 30 days
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • 30 days
|
|
Vascular disorders
Hypertensive crisis
|
2.0%
1/50 • 30 days
|
|
Vascular disorders
Ischaemia
|
2.0%
1/50 • 30 days
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
2.0%
1/50 • 30 days
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.0%
1/50 • 30 days
|
|
Investigations
Troponin increased
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.0%
1/50 • 30 days
|
Other adverse events
| Measure |
All Patients
n=50 participants at risk
VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous
VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
6/50 • 30 days
|
|
Gastrointestinal disorders
Constipation
|
4.0%
2/50 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Intestinal polyp
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Large intestine polyp
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Melaena
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Subileus
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Varices oesophageal
|
2.0%
1/50 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
4/50 • 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
2/50 • 30 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.0%
2/50 • 30 days
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.0%
1/50 • 30 days
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Pneumonia
|
12.0%
6/50 • 30 days
|
|
Infections and infestations
Endocarditis
|
4.0%
2/50 • 30 days
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • 30 days
|
|
Infections and infestations
Device related infection
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Gastroenteritis rotavirus
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Infectious pleural effusion
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Oesophageal candidiasis
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • 30 days
|
|
Infections and infestations
Urosepsis
|
2.0%
1/50 • 30 days
|
|
Investigations
Aspartate aminotransferase increased
|
6.0%
3/50 • 30 days
|
|
Investigations
Troponin increased
|
4.0%
2/50 • 30 days
|
|
Investigations
Bilirubin conjugated increased
|
4.0%
2/50 • 30 days
|
|
Investigations
C-reactive protein increased
|
4.0%
2/50 • 30 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.0%
2/50 • 30 days
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
1/50 • 30 days
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • 30 days
|
|
Investigations
Blood creatine phosphokinase abnormal
|
2.0%
1/50 • 30 days
|
|
Investigations
Blood creatinine increased
|
2.0%
1/50 • 30 days
|
|
Investigations
Brain natriuretic peptide increased
|
2.0%
1/50 • 30 days
|
|
Investigations
Procalcitonin abnormal
|
2.0%
1/50 • 30 days
|
|
Investigations
Procalcitonin increased
|
2.0%
1/50 • 30 days
|
|
General disorders
Pyrexia
|
6.0%
3/50 • 30 days
|
|
General disorders
Chest pain
|
2.0%
1/50 • 30 days
|
|
General disorders
Asthenia
|
2.0%
1/50 • 30 days
|
|
General disorders
Fatigue
|
2.0%
1/50 • 30 days
|
|
General disorders
Gait disturbance
|
2.0%
1/50 • 30 days
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.0%
1/50 • 30 days
|
|
General disorders
Pain
|
2.0%
1/50 • 30 days
|
|
General disorders
Xerosis
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
3/50 • 30 days
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.0%
1/50 • 30 days
|
|
Injury, poisoning and procedural complications
Wound
|
2.0%
1/50 • 30 days
|
|
Cardiac disorders
Cardiac failure
|
6.0%
3/50 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • 30 days
|
|
Cardiac disorders
Arrhythmia
|
2.0%
1/50 • 30 days
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
1/50 • 30 days
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/50 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
2/50 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.0%
2/50 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
2/50 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/50 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/50 • 30 days
|
|
Psychiatric disorders
Sleep disorder
|
10.0%
5/50 • 30 days
|
|
Psychiatric disorders
Delirium
|
2.0%
1/50 • 30 days
|
|
Psychiatric disorders
Depressed mood
|
2.0%
1/50 • 30 days
|
|
Psychiatric disorders
Disorientation
|
2.0%
1/50 • 30 days
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
5/50 • 30 days
|
|
Renal and urinary disorders
Azotaemia
|
2.0%
1/50 • 30 days
|
|
Renal and urinary disorders
End stage renal disease
|
2.0%
1/50 • 30 days
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.0%
1/50 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.0%
3/50 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic disorder
|
2.0%
1/50 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
2.0%
1/50 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • 30 days
|
|
Nervous system disorders
Syncope
|
4.0%
2/50 • 30 days
|
|
Nervous system disorders
Cerebral infarction
|
2.0%
1/50 • 30 days
|
|
Nervous system disorders
Dementia Alzheimer's type
|
2.0%
1/50 • 30 days
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • 30 days
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • 30 days
|
|
Nervous system disorders
Partial seizures
|
2.0%
1/50 • 30 days
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • 30 days
|
|
Vascular disorders
Hypertensive crisis
|
2.0%
1/50 • 30 days
|
|
Vascular disorders
Ischaemia
|
2.0%
1/50 • 30 days
|
|
Vascular disorders
Thrombophlebitis
|
2.0%
1/50 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
3/50 • 30 days
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.0%
1/50 • 30 days
|
|
Immune system disorders
Drug hypersensitivity
|
4.0%
2/50 • 30 days
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • 30 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
4.0%
2/50 • 30 days
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
2.0%
1/50 • 30 days
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • 30 days
|
|
Blood and lymphatic system disorders
Splenomegaly
|
2.0%
1/50 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
2.0%
1/50 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
2.0%
1/50 • 30 days
|
|
Congenital, familial and genetic disorders
Phimosis
|
2.0%
1/50 • 30 days
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • 30 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.0%
1/50 • 30 days
|
|
Social circumstances
Immobile
|
2.0%
1/50 • 30 days
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
2.0%
1/50 • 30 days
|
Additional Information
Prof. Dr. med. Kai Schmidt-Ott
Charité - Universitätsmedizin Berlin
Phone: +4930450614671
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place