Trial · NCT00464204
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization | until hemodynamic stabilization (up to 48 hours) | Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours. |
| Secondary | Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization | until hemodynamic stabilization (up to 48 hours) | Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization |
| Secondary | Quantity of Study Drug in 4 Days | 4 days | Total quantity of study drug infused over four consecutive days in the ICU |
| Secondary | Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition | Until start of enteral nutrition (up to 48 hours) | Time from start of fluid resuscitation with study drug to start of enteral nutrition. |
| Secondary | Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization | up to 48 hours | Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis. |
| Secondary | Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition | 7 days | This amount will be calculated from start of enteral nutrition until 7 am of day 8 |
| Secondary | Length of Stay in the Intensive Care Unit (ICU) | Until discharge from ICU (up to day 90) | Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value). |
| Secondary | Length of Stay in the ICU | Until discharge from ICU (up to Day 90) | Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., worst possible value). |
| Secondary | Length of Stay in the Hospital | Until discharge from hospital (up to day 90) | Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value). |
| Secondary | Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4 | From Screening to Day 4 | The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC). The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome). |
| Other | Mortality | From Screening to end of Follow-up | Mortality was reported for the time period from Screening until the end of follow-up. |
| Other | Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening | From screening to end of follow-up (up to day 90) | Acute Renal Failure (ARF) was defined as a two fold increase in serum concentration over the value at screening at any time after screening. |
| Other | Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification | From screening to end of follow-up | Acute Kidney Injury Network (AKIN) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. AKIN ranges from stage 1 to stage 3 (worst outcome). Stages differ in serum creatinine increase. Stage 1: Increase ≥ 0.3mg/dL or ≥ 150%-200% from reference; Stage 2: Increase ≥ 200%-300% from reference; Stage 3: Increase \>300% from reference with an acute increase of at least 0.5mg/dL or renal replacement therapy. |
| Other | Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification | From screening to end of follow-up | Risk, Injury, Failure, Loss, End-stage kidney disease (RIFLE) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. RIFLE comprises five categories: Risk (R), Injury (I), Failure (F), Loss (L), End-stage kidney disease (E) (worst outcome). R, I and F are based on increase in serum creatinine. L and E are based on administration of renal replacement therapy. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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