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The study is interventional, non-pharmacological, single-center. The aim of this study is to test the possible added value of CRRT in the surgery room during liver transplantation, compared to the investigators center current practice in which CRRT is suspended and possibly restarted at the end of the operation. The incidence of some clinical and metabolic alterations that often complicate transplantation in the absence of CRRT will be evaluated, by measuring a series of parameters related to the state of water filling, acid-base balance, general metabolic structure, hemodynamics and supportive drugs.
Some parameters related to patient safety will be evaluated. The results of this exploratory study will be useful to document what was rationally hypothesized, that is, that the continuation of dialysis treatment even during the hours of surgery, in this narrow category of patients, is actually useful to reduce the possible clinical and metabolic complications, intra- and/or post-operative (within 48 hours of transplant), linked to the simultaneous presence of renal failure.
The statistical analysis is aimed at analyzing the behavior of different indicators of clinical complications and comparing them with what was found in the historical series, in the hypothesis that with the new procedure the analyzed parameters are better. In detail, the mean values at the end of treatment will be compared for:
The following will also be evaluated:
The study is interventional, non-pharmacological, single-center. The clinical practice adopted to date provides that upon arrival of the liver to be transplanted, dialysis is interrupted before entering the surgery room, and then resumed, if necessary, upon exiting the room. The aim of this study is to test the possible added value of CRRT in the surgery room during liver transplantation, compared to the investigators center current practice. The incidence of some clinical and metabolic alterations that often complicate transplantation in the absence of CRRT will be evaluated, by measuring a series of parameters related to the state of water filling, acid-base balance, general metabolic structure, hemodynamics and supportive drugs. Some parameters related to patient safety will be evaluated.
For each patient enrolled in the study, the following will be collected:
baseline data (taken before entering the operating room), intraoperative data, postoperative data for the first 48 hours, and data at 3 and 6 months after surgery.
Baseline data:
Intra- and post-operative data:
The biochemical, hemodynamic and clinical parameters listed above will be recorded at the following times:
Data 3 and 6 months post intervention:
CRRT protocol:
The extracorporeal renal function replacement treatment modality adopted in the population under study is continuous veno-venous hemodiafiltration (CVVHDF) without anticoagulation. The Prismax® Baxter monitor will be used. A commercially available dialysis solution will be used and in particular: Prismasol 2 ® Baxter used both as dialysate and as post-dilution reinfusion, blood flow 150 ml/min; dialysis dose initially prescribed 30-35 ml/min which may be increased during treatment if necessary to obtain better metabolic/electrolytic control.
During the transplant, a dialysis nurse will be present in the surgery room for the entire duration of the operation. At the end of the operation, CRRT will continue in Intensive Care Unit.
The results of this exploratory study will be useful to document what was rationally hypothesized, that is, that the continuation of dialysis treatment even during the hours of surgery, in this narrow category of patients, is actually useful to reduce the possible clinical and metabolic complications, intra- and/or post-operative (within 48 hours of transplant), linked to the simultaneous presence of renal failure.
The statistical analysis is aimed at analyzing the behavior of different indicators of clinical complications and comparing them with what was found in the historical series, in the hypothesis that with the new procedure the analyzed parameters are better. In detail, the mean values at the end of treatment will be compared for:
The following will also be evaluated:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRRT during OLT | Other | CRRT during OLT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous renal replacement therapy | Other | continuous renal replacement therapy during OLT in surgery room |
|
| Measure | Description | Time Frame |
|---|---|---|
| central venous pressure average values at the end of treatment | Central venous pressure (cmH2O) | during surgery |
| Potassiemia average values at the end of tretment | Potassiemia (mmol/L) | during surgery |
| Lactatemia average values at the end of treatment | Lactatemia (mmol/L) | during surgery |
| pH average values at the end of treatment | pH (absolute value) | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| dose of vasocostrictors drugs | vasoconstrictor drugs, defined by the variation between the dose at the start of administration during the anhepatic phase and the maximum dose reached (mcg/Kg/min) | during surgery |
| pulmunary congestion |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 3 and 6 months post intervention | Survival (Yes/No) | 3 and 6 months post intervention |
| INR at 3 and 6 months post intervention | INR (International Normalized Ratio) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davide Ricci, Md, Phd | IRCCS Azienda ospedaliero-Universitaria di Bologna Policlinico di S'Orsola | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D000079664 | Continuous Renal Replacement Therapy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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The study is aimed at analyzing the behavior of different indicators of clinical complications and comparing them with what was found in the historical series, in the hypothesis that with the new procedure the analyzed parameters are better.
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pulmonary congestion/pulmonary edema, defined by radiological signs of alveolar congestion/edema on chest X-ray in the post-surgery period (Yes/NO)
| during surgery |
| safety parameters: episodes of hypokalemia | episodes of hypokalemia - K < 3.5 mmol/L - requiring supplementation (number of episodes) | during surgery |
| safety parameters: post-surgery hypophosphatemia | onset of hypophosphatemia <2.5 mg\dl (Yes/No) | during surgery |
| safety parameters: number of coagulation events in the extracorporeal circuit | intraoperative replacement of the extracorporeal circuit for TMP>200 (YES/NO) | during surgery |
| Safety parameters: appearance of cardiac arrhythmias | appearance of cardiac arrhythmias (Yes/No) | during surgery |
| 3 and 6 months post intervention |
| Bilirubin at 3 and 6 months post intervention | Bilirubin (mg/dL) | 3 and 6 months post intervention |
| Serum Creatinine at 3 and 6 months post intervention | Serum Creatinine (mg/dL) | 3 and 6 months post intervention |
| GFR at 3 and 6 months post intervention | GFR (mL/min/1.73 m2) | 3 and 6 months post intervention |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |