---
title: Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements
nct_id: NCT01516359
overall_status: UNKNOWN
sponsor: Cai Li
study_type: OBSERVATIONAL
primary_condition: Injury of Other and Multiple Parts of Small Intestine
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01516359.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01516359"
ct_last_update_post_date: 2012-01-24
last_seen_at: "2026-05-12T06:12:18.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements

**Official Title:** Official Title is Required by the WHO and ICMJE

**NCT ID:** [NCT01516359](https://clinicaltrials.gov/study/NCT01516359)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 1000
- **Lead Sponsor:** Cai Li
- **Conditions:** Injury of Other and Multiple Parts of Small Intestine
- **Start Date:** 2011-10
- **Completion Date:** 2012-11
- **CT.gov Last Update:** 2012-01-24

## Brief Summary

The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.

## Detailed Description

Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.

## Eligibility

- **Minimum age:** 16 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients undergoing heart valve replacements under cardiopulmonary bypass

Exclusion Criteria:

* Patients who die during or after operation
```

## Arms

- **patients with cardiac surgery**

## Primary Outcomes

- **score of gut dysfunction** _(time frame: eight months)_ — At different time points, gut dysfunction is graded according to previous criterion.

## Secondary Outcomes

- **The duration of cardiopulmonary bypass** _(time frame: Eight months)_
- **The duration for aortic artery clamping** _(time frame: eight months)_

## Locations (1)

- Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of anesthesiology, the first affiliated hospital, sun yat-sen university|guangzhou|guangdong|china` — added _(2026-05-12)_

---

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